Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-25 @ 4:13 PM
Study NCT ID:
NCT06115057
Status:
COMPLETED
Last Update Posted:
2024-02-06
First Post:
2023-09-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fiber Tolerance Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004043', 'term': 'Dietary Fiber'}], 'ancestors': [{'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'open-label, single-arm, single-site'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-05', 'studyFirstSubmitDate': '2023-09-18', 'studyFirstSubmitQcDate': '2023-10-30', 'lastUpdatePostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'GSRS', 'timeFrame': 'week 1, week 2, week 3, week 4', 'description': 'The reported severity of GI symptoms assessed by the GSRS between week 1 v week 2, week 1 v week 3, week 1 v week 4, week 2 v week 3, week 2 v week 4, and week 3 v week 4 \\[score\\].'}, {'measure': 'BSFC', 'timeFrame': 'week 1, week 4', 'description': 'Weekly average faecal form type assessed by the Bristol Stool Form Chart at each defecation in the baseline week, at week 1, and week 4 post-baseline.'}, {'measure': 'Defecation frequency', 'timeFrame': 'week 1, week 2, week 3, week 4', 'description': 'Weekly average frequency of defecation, derived from the number of faecal form types assessed by the Bristol Stool Form Chart.'}, {'measure': 'DQLQ', 'timeFrame': '4 weeks', 'description': 'Digestion-associated Quality of life assessed by the Digestion-associated Quality of Life Questionnaire (DQLQ) at baseline and at week 4 post-baseline.'}, {'measure': 'Stool', 'timeFrame': 'week 2, week 3, week 4', 'description': 'Microbiota and other outcome parameters assessed using collected faecal samples in the baseline week and every 7 days over 4 weeks post-baseline:\n\n* Composition, diversity, and abundance of microbiota using 16S rRNA gene sequencing and processing\n* Short-chain fatty acids (SCFA)\n* Branch-chain fatty acids (BCFA)\n* Lactate\n* Ammonia\n* Calprotectin\n* Secretory immunoglobulin A (sIgA)\n* pH'}], 'primaryOutcomes': [{'measure': 'GSRS change', 'timeFrame': '4 weeks', 'description': 'Change from baseline in the reported severity of GI symptoms assessed by the Gastrointestinal Symptom Rating Scale (GSRS) for diarrhea dimension at week 4 post-baseline.'}], 'secondaryOutcomes': [{'measure': 'GSRS change', 'timeFrame': 'week 1, week 2, week 3,', 'description': 'Weekly changes from baseline in the reported severity of GI symptoms assessed by the GSRS for diarrhea dimension at week 1, week 2, and week 3 post-baseline.'}, {'measure': 'GSRS change', 'timeFrame': 'week 1, week 2, week 3, week 4', 'description': 'Weekly changes from baseline in the reported severity of GI symptoms assessed by the GSRS for abdominal pain, constipation, indigestion, and reflux dimensions at week 1, week 2, week 3, and week 4.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fiber Tolerance Gastro-intestinal Safety'], 'conditions': ['Gastrointestinal Tolerance of Dietary Fiber']}, 'descriptionModule': {'briefSummary': 'Research shows that many people do not get enough dietary fiber through their normal diet. As a result, some nutrients are not properly absorbed into the bloodstream. The immune system however does need these nutrients. Dietary fibers are therefore important for health. Nutricia has developed a new blend of natural fibers that can help people get enough fiber.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥ 45 and ≤ 70 years\n2. Body Mass Index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2\n3. Signed consent form\n4. Willingness and ability to comply with the protocol\n5. Good general health\n6. Defecation frequency: between three bowel movements per week and three bowel movements per day within a month for screening.\n\nExclusion Criteria:\n\n1. Presence or history of chronic gastrointestinal disorders (e.g. stomach ulcers, ulcerative colitis, Crohn's disease) or history of abdominal surgery with resection of the bowel (small or large intestine).\n2. Presence of other medical conditions where gastrointestinal function often/probably is affected, such as:\n\n 1. autoimmune diseases (e.g. diabetes mellitus type I, multiple sclerosis, systemic lupus erythematosus).\n 2. eating disorders (e.g. anorexia nervosa, bulimia nervosa, binge eating disorder).\n 3. intestinal/gastrointestinal disorder due to a stroke.\n3. Chronic diseases (including but not limited to hypertension, dyslipidaemia, type 2 diabetes mellitus, thyroid disorders) that cannot be controlled with the use of medication/therapy.\n4. Severe acute liver disease or chronic liver disease.\n5. Severe or chronic kidney disease or need for hemodialysis.\n6. Colonoscopy, irrigoscopy or other bowel cleansing, or other surgical procedures related to the gastrointestinal tract (eg. colon polypectomy, appendectomy) or for which use of systemic antibiotics within 1 month before the screening is required or scheduled during participation in the study.\n7. Use of enemas, laxatives, antacids, proton pump inhibitors, prokinetics (e.g. metoclopramide, drugs that affect motility), digestive enzymes, narcotic/morphine analgesics within 1 week prior to screening or intended use during participation in the study.\n8. Following a vegetarian or vegan diet."}, 'identificationModule': {'nctId': 'NCT06115057', 'acronym': 'Gitomix', 'briefTitle': 'Fiber Tolerance Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nutricia Research'}, 'officialTitle': 'The Investigation of Gastrointestinal Tolerance of a Novel Fibre Blend Among ≥45-<70-year-old Men and Women', 'orgStudyIdInfo': {'id': '23REX0058665'}, 'secondaryIdInfos': [{'id': 'NL84292.056.23', 'type': 'OTHER', 'domain': 'CCMO, The Netherlands'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Fiber', 'interventionNames': ['Dietary Supplement: Fiber']}], 'interventions': [{'name': 'Fiber', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Subjects in this study are to consume the study product twice daily during regular meals.\n\nThe fiber mix consists of different types of dietary fiber that are individually well tolerated for human consumption.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3584CT', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Nutrition Clinical Research Unit', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nutricia Research', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'NCRU (Nutrition Clinical Research Unit)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}