Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-25 @ 5:25 PM
Study NCT ID:
NCT05541003
Status:
COMPLETED
Last Update Posted:
2024-07-16
First Post:
2022-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Understanding the Role of Gut Microbiota in Hyperphagia in Prader-Willi Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011218', 'term': 'Prader-Willi Syndrome'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D000096803', 'term': 'Imprinting Disorders'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kk1132@rwjms.rutgers.edu', 'phone': '6784690425', 'title': 'Dr. Keerthana Kesavarapu', 'organization': 'Robert Wood Johnson'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'There was a variance in BMI in patients accepted. We anticipate this led the varied difference in response in data. Additionally, two of the patients had PWS while the remainder of patients had non-genetic obesity. We anticipate this also led to the varied difference in response in data.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'Patients are asked to keep a supplement log. On this log patients record if and when they take the fiber supplement and any side effects. Only 10 participants took fiber supplement.', 'eventGroups': [{'id': 'EG000', 'title': 'Fiber Intervention', 'description': 'All patients were given 48 grams of NBT-NM108 dietary fiber in the form of 2 muffins per day', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Microbiome Analysis: Alpha Diversity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microbiome Structure', 'description': 'In this pilot study, we collected 20 fecal samples from 10 subjects before and after the dietary intervention. We extracted the metagenomic DNA from the fecal samples and applied 16S rRNA gene amplicon sequencing to understand the impact of NBT-NM108 on the gut microbiome. We obtained \\~980,000 high-quality sequencing reads from 20 samples and have identified 757 amplicon sequence variants (ASVs) from these samples. For subsequent analysis the number of sequencing reads per sample was normalized to 34,000 per sample. Alpha and beta diversity were analyzed to assess changes of the overall gut microbiota structure. Alpha diversity describes the overall gut microbiota structure within a single sample.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.89', 'spread': '0.46', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0', 'description': 'Alpha Diversity measured by Shannon index. The Shannon Index is a measure of diversity of microbial species that takes into account both abundance (the number of species present) and evenness (how close the numbers for each species are). The Shannon index can be calculated using the following equation: H= -∑(i=1)\\^s pi ln(pi). A value of zero for H indicates that a community has only one species. The higher the value of H, the higher the diversity of species in a particular community.', 'unitOfMeasure': 'Shannon index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Alpha Diversity measured by Shannon index. The Shannon Index is a measure of diversity of microbial species that takes into account both abundance (the number of species present) and evenness (how close the numbers for each species are). The Shannon index can be calculated using the following equation: H= -∑(i=1)\\^s pi ln(pi). A value of zero for H indicates that a community has only one species. The higher the value of H, the higher the diversity of species in a particular community. No units.'}, {'type': 'PRIMARY', 'title': 'Microbiome Analysis: Alpha Diversity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microbiome Structure: Alpha Diversity', 'description': 'For alpha diversity, Shannon index and observed number of ASVs were used for assessment. Both the indices were computed for each sample and are represented as Mean (Standard deviation).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.73', 'spread': '0.41', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'Alpha diversity measured by Shannon index. "The Shannon Index is a measure of diversity of microbial species that takes into account both abundance (the number of species present) and evenness (how close the numbers for each species are). The Shannon index can be calculated using the following equation: H= -∑(i=1)\\^s pi ln(pi). A value of zero for H indicates that a community has only one species. The higher the value of H, the higher the diversity of species in a particular community.', 'unitOfMeasure': 'Shannon index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For alpha diversity, Shannon index was used.'}, {'type': 'PRIMARY', 'title': 'Microbiome Analysis: Beta Diversity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microbiome: Beta Diversity', 'description': 'For beta diversity, Bray-Curtis dissimilarity index was computed for each sample. Bray-Curtis dissimilarity index is represented as Median (Inter-Quartile Range).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.76', 'groupId': 'OG000', 'lowerLimit': '0.65', 'upperLimit': '0.81'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 0', 'description': 'The Bray-Curtis distance was used to compute the distances for each sample. Bray-Curtis distance uses species abundance information and membership to calculate the distance between samples. The Bray-Curtis dissimilarity index for a sample ranges between 0 and 1. A value of 0 indicates no difference between the samples, while a value of 1 represents the maximum distance between them', 'unitOfMeasure': 'Bray-Curtis distance', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'For beta diversity, Bray-Curtis dissimilarity index was computed for each sample. Bray-Curtis dissimilarity index is represented as Median (Inter-Quartile Range).'}, {'type': 'SECONDARY', 'title': 'Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiber Intervention', 'description': 'All patients were given 48 grams of NBT-NM108 dietary fiber in the form of 2 muffins per day'}], 'classes': [{'categories': [{'measurements': [{'value': '107', 'spread': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'Weight in kg', 'unitOfMeasure': 'Kilogram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Acyl-Ghrelin Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiber Intervention', 'description': 'All patients were given 48 grams of NBT-NM108 dietary fiber in the form of 2 muffins per day'}], 'classes': [{'title': 'Early Response', 'categories': [{'measurements': [{'value': '13.47', 'spread': '22.54', 'groupId': 'OG000'}]}]}, {'title': 'Late Response', 'categories': [{'measurements': [{'value': '187', 'spread': '191', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': 'Early response to meal post-intervention is 0-30min. Late response phase to meal post-intervention is 60-180min.', 'unitOfMeasure': 'pg*min/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Looking at iAUC for early and late response phases after meal.'}, {'type': 'SECONDARY', 'title': 'Acyl-Ghrelin Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiber Intervention', 'description': 'All patients were given 48 grams of NBT-NM108 dietary fiber in the form of 2 muffins per day'}], 'classes': [{'title': 'Early Response', 'categories': [{'measurements': [{'value': '12.5', 'spread': '17.6', 'groupId': 'OG000'}]}]}, {'title': 'Late Response', 'categories': [{'measurements': [{'value': '278', 'spread': '605', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'Early response to meal post-intervention is 0-30min. Late response phase to meal post-intervention is 60-180min.', 'unitOfMeasure': 'pg*min/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Looking at iAUC for early and late response phases after meal.'}, {'type': 'SECONDARY', 'title': 'Peptide YY (PYY)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiber Intervention', 'description': 'All patients were given 48 grams of NBT-NM108 dietary fiber in the form of 2 muffins per day'}], 'classes': [{'title': 'early phase (0-30min)', 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.37', 'groupId': 'OG000'}]}]}, {'title': 'late phase response (60-180min)', 'categories': [{'measurements': [{'value': '4.01', 'spread': '4.22', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': 'Early response to meal post-intervention is 0-30min. Late response phase to meal post-intervention is 60-180min.', 'unitOfMeasure': 'pg*min/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Looking at iAUC for early and late response phases after meal.'}, {'type': 'SECONDARY', 'title': 'Peptide YY (PYY)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiber Intervention', 'description': 'All patients were given 48 grams of NBT-NM108 dietary fiber in the form of 2 muffins per day'}], 'classes': [{'title': 'early phase (0-30min)', 'categories': [{'measurements': [{'value': '0.614', 'spread': '1.43', 'groupId': 'OG000'}]}]}, {'title': 'late phase response (60-180min)', 'categories': [{'measurements': [{'value': '11.1', 'spread': '14.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'Early response to meal post-intervention is 0-30min. Late response phase to meal post-intervention is 60-180min.', 'unitOfMeasure': 'pg*min/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Looking at iAUC for early and late response phase after meal.'}, {'type': 'SECONDARY', 'title': 'Glucagon Like Peptide 1 (GLP1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiber Intervention', 'description': 'All patients were given 48 grams of NBT-NM108 dietary fiber in the form of 2 muffins per day'}], 'classes': [{'title': 'early phase (0-30min)', 'categories': [{'measurements': [{'value': '10.6', 'spread': '15.8', 'groupId': 'OG000'}]}]}, {'title': 'late phase response (60-180min)', 'categories': [{'measurements': [{'value': '115', 'spread': '184', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': 'GLP1 levels were measured in patients before fiber intervention. Early response to meal post-intervention is 0-30min. Late response phase to meal post-intervention is 60-180min.', 'unitOfMeasure': 'pg*min/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Looking at iAUC for early and late response phase after meal.'}, {'type': 'SECONDARY', 'title': 'Glucagon Like Peptide 1 (GLP1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiber Intervention', 'description': 'All patients were given 48 grams of NBT-NM108 dietary fiber in the form of 2 muffins per day'}], 'classes': [{'title': 'early phase (0-30min)', 'categories': [{'measurements': [{'value': '4.44', 'spread': '6.85', 'groupId': 'OG000'}]}]}, {'title': 'late phase response (60-180min)', 'categories': [{'measurements': [{'value': '79.6', 'spread': '55.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'GLP1 levels were measured in patients after fiber intervention. Early response to meal post-intervention is 0-30min. Late response phase to meal post-intervention is 60-180min.', 'unitOfMeasure': 'pg*min/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Looking at iAUC for early and late response phase after meal.'}, {'type': 'SECONDARY', 'title': 'Insulin Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiber Intervention', 'description': 'All patients were given 48 grams of NBT-NM108 dietary fiber in the form of 2 muffins per day'}], 'classes': [{'title': 'early phase (0-30min)', 'categories': [{'measurements': [{'value': '1660', 'spread': '716', 'groupId': 'OG000'}]}]}, {'title': 'late phase response (60-180min)', 'categories': [{'measurements': [{'value': '6361', 'spread': '3978', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': 'Insulin levels were measured in patients before fiber intervention. Early response to meal post-intervention is 0-30min. Late response phase to meal post-intervention is 60-180min.', 'unitOfMeasure': 'µIU*min/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Looking at iAUC for early and late response phase after meal.'}, {'type': 'SECONDARY', 'title': 'Insulin Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiber Intervention', 'description': 'All patients were given 48 grams of NBT-NM108 dietary fiber in the form of 2 muffins per day'}], 'classes': [{'title': 'early phase (0-30min)', 'categories': [{'measurements': [{'value': '1607', 'spread': '783', 'groupId': 'OG000'}]}]}, {'title': 'late phase response (60-180min)', 'categories': [{'measurements': [{'value': '7427', 'spread': '3644', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'Insulin levels were measured in patients after fiber intervention. Early response to meal post-intervention is 0-30min. Late response phase to meal post-intervention is 60-180min.', 'unitOfMeasure': 'µIU*min/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Looking at iAUC for early and late response phase after meal.'}, {'type': 'SECONDARY', 'title': 'Glucose Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiber Intervention', 'description': 'All patients were given 48 grams of NBT-NM108 dietary fiber in the form of 2 muffins per day'}], 'classes': [{'title': 'early phase (0-30min)', 'categories': [{'measurements': [{'value': '264', 'spread': '288', 'groupId': 'OG000'}]}]}, {'title': 'late phase response (60-180min)', 'categories': [{'measurements': [{'value': '301', 'spread': '503', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': 'Glucose levels were measured in patients before fiber intervention. Early phase (0-30min) and late phase response (60-180min) to a mixed meal tolerance test was collected.', 'unitOfMeasure': 'mmol*min/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Looking at iAUC for early and late response phase after meal.'}, {'type': 'SECONDARY', 'title': 'Glucose Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiber Intervention', 'description': 'All patients were given 48 grams of NBT-NM108 dietary fiber in the form of 2 muffins per day'}], 'classes': [{'title': 'early phase (0-30min)', 'categories': [{'measurements': [{'value': '182', 'spread': '222', 'groupId': 'OG000'}]}]}, {'title': 'late phase response (60-180min)', 'categories': [{'measurements': [{'value': '375', 'spread': '552', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'Glucose levels were measured in patients after fiber intervention. Early phase (0-30min) and late phase response (60-180min) to a mixed meal tolerance test was collected.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Glucose levels were measured in patients after fiber intervention. Early phase (0-30min) and late phase response (60-180min) to a mixed meal tolerance test was collected.'}, {'type': 'SECONDARY', 'title': 'Calorie Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiber Intervention', 'description': 'All patients were given 48 grams of NBT-NM108 dietary fiber in the form of 2 muffins per day'}], 'classes': [{'categories': [{'measurements': [{'value': '1638', 'spread': '493', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': '24 hour dietary recall recorded in MyFitnessPal application measured in kcal.', 'unitOfMeasure': 'Kcal', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Calorie Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiber Intervention', 'description': 'All patients were given 48 grams of NBT-NM108 dietary fiber in the form of 2 muffins per day'}], 'classes': [{'categories': [{'measurements': [{'value': '1840', 'spread': '564', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': '24 hour dietary recall recorded in MyFitnessPal application measured in kcal.', 'unitOfMeasure': 'Kcal', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hyperphagia Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiber Intervention', 'description': 'All patients were given 48 grams of NBT-NM108 dietary fiber in the form of 2 muffins per day'}], 'classes': [{'title': 'Hyperphagia behavior', 'categories': [{'measurements': [{'value': '6.18', 'spread': '1.83', 'groupId': 'OG000'}]}]}, {'title': 'Hyperphagia drive', 'categories': [{'measurements': [{'value': '6.54', 'spread': '2.20', 'groupId': 'OG000'}]}]}, {'title': 'Hyperphagia severity', 'categories': [{'measurements': [{'value': '3.63', 'spread': '1.69', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': 'Appetite behavior measured by questionnaire measured by likert scale. The scores should improve from week 0 to week 4. Higher scores indicate worse hyperphagia.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The questionnaire includes 11 questions measured on a 5-point Likert scale, which are summarized in a total hyperphagia score (range: 11-55). Three subscores were summed: hyperphagic behavior (range: 5-25), hyperphagic drive (range: 4-20) and hyperphagic severity (range: 2-10). The scores should improve from week 0 to week 4 with intervention. Higher scores indicate worse hyperphagia. Our scores reported below are mean +/- standard deviation and not ranges.'}, {'type': 'SECONDARY', 'title': 'Hyperphagia Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiber Intervention', 'description': 'All patients were given 48 grams of NBT-NM108 dietary fiber in the form of 2 muffins per day'}], 'classes': [{'title': 'Hyperphagia behavior', 'categories': [{'measurements': [{'value': '5.3', 'spread': '1.7', 'groupId': 'OG000'}]}]}, {'title': 'Hyperphagia drive', 'categories': [{'measurements': [{'value': '5.7', 'spread': '1.7', 'groupId': 'OG000'}]}]}, {'title': 'Hyperphagia severity', 'categories': [{'measurements': [{'value': '3.1', 'spread': '1.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'Appetite behavior measured by questionnaire measured by likert scale. The scores should improve from week 0 to week 4. Higher scores indicate worse hyperphagia. The questionnaire includes 11 questions measured on a 5-point Likert scale, which are summarized in a total hyperphagia score (range: 11-55). Three subscores were summed: hyperphagic behavior (range: 5-25), hyperphagic drive (range: 4-20) and hyperphagic severity (range: 2-10). The scores should improve from week 0 to week 4 with intervention. Higher scores indicate worse hyperphagia.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The questionnaire includes 11 questions measured on a 5-point Likert scale, which are summarized in a total hyperphagia score (range: 11-55). Three subscores were summed: hyperphagic behavior (range: 5-25), hyperphagic drive (range: 4-20) and hyperphagic severity (range: 2-10). The scores should improve from week 0 to week 4 with intervention. Higher scores indicate worse hyperphagia. Our scores reported below are mean +/- standard deviation and not ranges.'}, {'type': 'PRIMARY', 'title': 'Microbiome Analysis: Beta Diversity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microbiome: Beta Diversity', 'description': 'For beta diversity, Bray-Curtis dissimilarity index was computed for each sample. Bray-Curtis dissimilarity index is represented as Median (Inter-Quartile Range).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.73', 'groupId': 'OG000', 'lowerLimit': '0.64', 'upperLimit': '0.79'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 4', 'description': 'The Bray-Curtis distance was used to compute the distances for each sample. Bray-Curtis distance uses species abundance information and membership to calculate the distance between samples. The Bray-Curtis dissimilarity index for a sample ranges between 0 and 1. A value of 0 indicates no difference between the samples, while a value of 1 represents the maximum distance between them', 'unitOfMeasure': 'Bray-Curtis distance', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'For beta diversity, Bray-Curtis dissimilarity index was computed for each sample.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental Arm', 'description': 'All participants will receive NBT-NM108 prepared as muffin (each contains 30 g of the product) for 4 weeks. The dosage will be 2 muffins a day. This dosage of NBT-NM108 will provide 24 g/day of dietary fibers.\n\nNBT-NM108: All patients will consume NBT-NM108 in the form of 2 muffins daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Recruitment time period was from 11/1/2022 to 3/1/2023. Recruitment occurred from Robert Wood Johnson medical clinics.', 'preAssignmentDetails': 'No patients were excluded from the study before assignment to arms or groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Fiber Intervention', 'description': 'All patients were given 48 grams of NBT-NM108 dietary fiber in the form of 2 muffins per day'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '28', 'spread': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '107.01', 'spread': '21.33', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Weight of individual before fiber intervention.', 'unitOfMeasure': 'kilogram', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '38.58', 'spread': '7.82', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic Blood Pressure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '135', 'spread': '13.64', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic Blood Pressure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '88.91', 'spread': '9.63', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Heart Rate', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '81.55', 'spread': '15.92', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-12', 'size': 1225784, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-02-20T11:05', 'hasProtocol': True}, {'date': '2023-04-12', 'size': 266979, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-02-20T10:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-11', 'studyFirstSubmitDate': '2022-09-01', 'resultsFirstSubmitDate': '2024-02-20', 'studyFirstSubmitQcDate': '2022-09-14', 'lastUpdatePostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-11', 'studyFirstPostDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microbiome Analysis: Alpha Diversity', 'timeFrame': 'Weeks 0', 'description': 'Alpha Diversity measured by Shannon index. The Shannon Index is a measure of diversity of microbial species that takes into account both abundance (the number of species present) and evenness (how close the numbers for each species are). The Shannon index can be calculated using the following equation: H= -∑(i=1)\\^s pi ln(pi). A value of zero for H indicates that a community has only one species. The higher the value of H, the higher the diversity of species in a particular community.'}, {'measure': 'Microbiome Analysis: Alpha Diversity', 'timeFrame': 'Week 4', 'description': 'Alpha diversity measured by Shannon index. "The Shannon Index is a measure of diversity of microbial species that takes into account both abundance (the number of species present) and evenness (how close the numbers for each species are). The Shannon index can be calculated using the following equation: H= -∑(i=1)\\^s pi ln(pi). A value of zero for H indicates that a community has only one species. The higher the value of H, the higher the diversity of species in a particular community.'}, {'measure': 'Microbiome Analysis: Beta Diversity', 'timeFrame': 'Week 0', 'description': 'The Bray-Curtis distance was used to compute the distances for each sample. Bray-Curtis distance uses species abundance information and membership to calculate the distance between samples. The Bray-Curtis dissimilarity index for a sample ranges between 0 and 1. A value of 0 indicates no difference between the samples, while a value of 1 represents the maximum distance between them'}, {'measure': 'Microbiome Analysis: Beta Diversity', 'timeFrame': 'Week 4', 'description': 'The Bray-Curtis distance was used to compute the distances for each sample. Bray-Curtis distance uses species abundance information and membership to calculate the distance between samples. The Bray-Curtis dissimilarity index for a sample ranges between 0 and 1. A value of 0 indicates no difference between the samples, while a value of 1 represents the maximum distance between them'}], 'secondaryOutcomes': [{'measure': 'Weight', 'timeFrame': 'Week 4', 'description': 'Weight in kg'}, {'measure': 'Acyl-Ghrelin Level', 'timeFrame': 'Week 0', 'description': 'Early response to meal post-intervention is 0-30min. Late response phase to meal post-intervention is 60-180min.'}, {'measure': 'Acyl-Ghrelin Level', 'timeFrame': 'Week 4', 'description': 'Early response to meal post-intervention is 0-30min. Late response phase to meal post-intervention is 60-180min.'}, {'measure': 'Peptide YY (PYY)', 'timeFrame': 'Week 0', 'description': 'Early response to meal post-intervention is 0-30min. Late response phase to meal post-intervention is 60-180min.'}, {'measure': 'Peptide YY (PYY)', 'timeFrame': 'Week 4', 'description': 'Early response to meal post-intervention is 0-30min. Late response phase to meal post-intervention is 60-180min.'}, {'measure': 'Glucagon Like Peptide 1 (GLP1)', 'timeFrame': 'Week 0', 'description': 'GLP1 levels were measured in patients before fiber intervention. Early response to meal post-intervention is 0-30min. Late response phase to meal post-intervention is 60-180min.'}, {'measure': 'Glucagon Like Peptide 1 (GLP1)', 'timeFrame': 'Week 4', 'description': 'GLP1 levels were measured in patients after fiber intervention. Early response to meal post-intervention is 0-30min. Late response phase to meal post-intervention is 60-180min.'}, {'measure': 'Insulin Level', 'timeFrame': 'Week 0', 'description': 'Insulin levels were measured in patients before fiber intervention. Early response to meal post-intervention is 0-30min. Late response phase to meal post-intervention is 60-180min.'}, {'measure': 'Insulin Level', 'timeFrame': 'Week 4', 'description': 'Insulin levels were measured in patients after fiber intervention. Early response to meal post-intervention is 0-30min. Late response phase to meal post-intervention is 60-180min.'}, {'measure': 'Glucose Level', 'timeFrame': 'Week 0', 'description': 'Glucose levels were measured in patients before fiber intervention. Early phase (0-30min) and late phase response (60-180min) to a mixed meal tolerance test was collected.'}, {'measure': 'Glucose Level', 'timeFrame': 'Week 4', 'description': 'Glucose levels were measured in patients after fiber intervention. Early phase (0-30min) and late phase response (60-180min) to a mixed meal tolerance test was collected.'}, {'measure': 'Calorie Count', 'timeFrame': 'Week 0', 'description': '24 hour dietary recall recorded in MyFitnessPal application measured in kcal.'}, {'measure': 'Calorie Count', 'timeFrame': 'Week 4', 'description': '24 hour dietary recall recorded in MyFitnessPal application measured in kcal.'}, {'measure': 'Hyperphagia Questionnaire', 'timeFrame': 'Week 0', 'description': 'Appetite behavior measured by questionnaire measured by likert scale. The scores should improve from week 0 to week 4. Higher scores indicate worse hyperphagia.'}, {'measure': 'Hyperphagia Questionnaire', 'timeFrame': 'Week 4', 'description': 'Appetite behavior measured by questionnaire measured by likert scale. The scores should improve from week 0 to week 4. Higher scores indicate worse hyperphagia. The questionnaire includes 11 questions measured on a 5-point Likert scale, which are summarized in a total hyperphagia score (range: 11-55). Three subscores were summed: hyperphagic behavior (range: 5-25), hyperphagic drive (range: 4-20) and hyperphagic severity (range: 2-10). The scores should improve from week 0 to week 4 with intervention. Higher scores indicate worse hyperphagia.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prader-Willi Syndrome', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '8220655', 'type': 'BACKGROUND', 'citation': 'Holland AJ, Treasure J, Coskeran P, Dallow J, Milton N, Hillhouse E. Measurement of excessive appetite and metabolic changes in Prader-Willi syndrome. Int J Obes Relat Metab Disord. 1993 Sep;17(9):527-32.'}, {'pmid': '9526967', 'type': 'BACKGROUND', 'citation': 'Fieldstone A, Zipf WB, Sarter MF, Berntson GG. Food intake in Prader-Willi syndrome and controls with obesity after administration of a benzodiazepine receptor agonist. Obes Res. 1998 Jan;6(1):29-33. doi: 10.1002/j.1550-8528.1998.tb00311.x.'}, {'pmid': '30569567', 'type': 'BACKGROUND', 'citation': 'Proffitt J, Osann K, McManus B, Kimonis VE, Heinemann J, Butler MG, Stevenson DA, Gold JA. Contributing factors of mortality in Prader-Willi syndrome. Am J Med Genet A. 2019 Feb;179(2):196-205. doi: 10.1002/ajmg.a.60688. Epub 2018 Dec 19.'}, {'pmid': '26713776', 'type': 'BACKGROUND', 'citation': 'Martinez Michel L, Haqq AM, Wismer WV. A review of chemosensory perceptions, food preferences and food-related behaviours in subjects with Prader-Willi Syndrome. Appetite. 2016 Apr 1;99:17-24. doi: 10.1016/j.appet.2015.12.021. Epub 2015 Dec 20.'}, {'pmid': '26425705', 'type': 'BACKGROUND', 'citation': 'Zhang C, Yin A, Li H, Wang R, Wu G, Shen J, Zhang M, Wang L, Hou Y, Ouyang H, Zhang Y, Zheng Y, Wang J, Lv X, Wang Y, Zhang F, Zeng B, Li W, Yan F, Zhao Y, Pang X, Zhang X, Fu H, Chen F, Zhao N, Hamaker BR, Bridgewater LC, Weinkove D, Clement K, Dore J, Holmes E, Xiao H, Zhao G, Yang S, Bork P, Nicholson JK, Wei H, Tang H, Zhang X, Zhao L. Dietary Modulation of Gut Microbiota Contributes to Alleviation of Both Genetic and Simple Obesity in Children. EBioMedicine. 2015 Jul 10;2(8):968-84. doi: 10.1016/j.ebiom.2015.07.007. eCollection 2015 Aug.'}, {'pmid': '21722955', 'type': 'BACKGROUND', 'citation': 'Purtell L, Sze L, Loughnan G, Smith E, Herzog H, Sainsbury A, Steinbeck K, Campbell LV, Viardot A. In adults with Prader-Willi syndrome, elevated ghrelin levels are more consistent with hyperphagia than high PYY and GLP-1 levels. Neuropeptides. 2011 Aug;45(4):301-7. doi: 10.1016/j.npep.2011.06.001. Epub 2011 Jul 1.'}, {'pmid': '17636101', 'type': 'BACKGROUND', 'citation': 'Dykens EM, Maxwell MA, Pantino E, Kossler R, Roof E. Assessment of hyperphagia in Prader-Willi syndrome. Obesity (Silver Spring). 2007 Jul;15(7):1816-26. doi: 10.1038/oby.2007.216.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to use a high-fiber supplementation, an intervention known to create shifts in the gut microbiota towards a healthier structure, to explore the relationship between gut microbiota, appetite control and feeding behavior in PWS patients.', 'detailedDescription': 'This study is recruiting PWS patients aged 18-35 years who have not received growth hormone treatment in the previous 6 months. Study candidates will be recruited from Robert Wood Johnson. Participants will attend a baseline visit at the Center for Advanced Human Brain Imaging Research (CAHBIR) at Rutgers University, during which functional magnetic resonance imaging (fMRI) coupled with a meal test will be performed to assess peripheral and central feeding pathways (7, 8). fMRI scans will be performed during resting state to assess functional connectivity of feeding related networks, with a specific focus on connectivity between the hypothalamus, insula, anterior cingulate, ventromedial/orbitofrontal prefrontal cortex and amygdala (9, 10). Activation to food (vs non-food) images will be assessed to index responsivity to appetitive feeding networks including the above regions and the ventral striatum using paradigms that have previously been found to be sensitive to trait and state in multiple studies (11-13). Thereafter participants will consume a liquid meal (525 kcal; Ensure Plus, Abbott). fMRI will be repeated immediately after the meal. Participants will obtain laboratory work coupled with a meal test to assess satiety hormones and inflammatory markers. Fasting blood draw will be taken, and the participants will consume a liquid meal (525 kcal; Ensure Plus, Abbot) followed by blood draws at 30, 60, 120, 180 and 240 min post-meal. Upon completion of baseline testing and providing a fecal sample, participants will consume NBT-NM108 (a mixture of inulin, Fibersol-2, and brans of oat, wheat, corn and sorghum; Notitia Biotechnologies) daily for 4 weeks. At the completion of the 4-week intervention, all sampling and testing will be repeated as per baseline. At baseline and end of intervention, participants will be interviewed with appetite and physical activity questionnaires (Appendix C and G) and requested to complete a 24-h food recall using MyFitnessPal, a mobile health app on their phone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 18-35 (inclusive)\n* Confirmed PWS with genetic testing\n* No growth hormone treatment in the previous 6 months\n* Body weight \\< 300 lbs.\n\nExclusion Criteria:\n\n* History of other gastrointestinal disorders such as small intestinal bacterial overgrowth, celiac disease, inflammatory bowel disease, or irritable bowel syndrome.\n* Pregnancy or breastfeeding\n* Prior gastrointestinal or bariatric surgery\n* Immunocompromised e.g., cancer treatment, bone marrow/organ transplant, immune deficiency, poorly controlled HIV/AIDS, prolonged use of steroids or other immunosuppressant medications\n* Antibiotic administration in the previous 30 days\n* Participation in other weight-loss programs in the previous 3 months.\n* Administration of pre/probiotic supplements or antibiotics.\n* Growth hormone administration in the previous 6 months\n* Must have access to a smartphone, tablet, computer, or other qualifying internet-enabled device and be able to follow instructions.\n* Individuals who are not proficient in English\n* Contraindications for MRI scanning, including Ferrous material implanted in or on the body, including flakes or filings, surgical clips, bullets, or electrical devices such as a pacemaker, or nonremovable ferrous jewelry (fillings in teeth and permanent retainers are permitted). Individuals with surgical pins or plates above the neck are excluded. Surgical pins or plates below the neck are exclusions, except when the material is fixed to bone, and considered acceptable by the Reference Manual for Magnetic Resonance Safety. Implants and Devices, 2020 Edition. Almost all recent orthopedic implants are made of materials that are not ferromagnetic and therefore are safe for scanning, and even though some screws are still made of ferromagnetic materials these are firmly screwed into bone. In cases where the material is unknown or deemed unsafe for scanning by the Reference Manual for Magnetic Resonance Safety. Implants and Devices, the participant will be excluded. History of eye injury involving metallic materials, shavings in eyes, or welding without a face mask. Lead/iron tattoos and tattoos performed by a nonprofessional artist if the pigment material is unknown. Claustrophobia (history of significant anxiety in closed places).\n* Back problem that would prevent the subject from laying still comfortably for up to 60 minutes.'}, 'identificationModule': {'nctId': 'NCT05541003', 'acronym': 'PWSGUT', 'briefTitle': 'Understanding the Role of Gut Microbiota in Hyperphagia in Prader-Willi Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Understanding the Role of Gut Microbiota in Hyperphagia in Prader-Willi Syndrome', 'orgStudyIdInfo': {'id': 'Pro2022000828'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Arm', 'description': 'All participants will receive NBT-NM108 prepared as muffin (each contains 30 g of the product) for 4 weeks. The dosage will be 2 muffins a day. This dosage of NBT-NM108 will provide 24 g/day of dietary fibers.', 'interventionNames': ['Drug: NBT-NM108']}], 'interventions': [{'name': 'NBT-NM108', 'type': 'DRUG', 'description': 'All patients will consume NBT-NM108 in the form of 2 muffins daily.', 'armGroupLabels': ['Experimental Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Robert Wood Johnson University Hospital', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Keerthana Kesavarapu, D.O.', 'investigatorAffiliation': 'Rutgers, The State University of New Jersey'}}}}