Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-25 @ 5:31 PM
Study NCT ID:
NCT05791604
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2023-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Intervention of Obesity in Children With Prader-Willi Syndrome Using Prebiotics and Probiotics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011218', 'term': 'Prader-Willi Syndrome'}], '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': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D056692', 'term': 'Prebiotics'}, {'id': 'C012990', 'term': 'galactomannan'}, {'id': 'C120489', 'term': 'oligofructose'}], 'ancestors': [{'id': 'D004043', 'term': 'Dietary Fiber'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011135', 'term': 'Polysaccharides, Bacterial'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-05', 'size': 362692, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2023-03-17T01:01', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-10', 'studyFirstSubmitDate': '2023-03-06', 'studyFirstSubmitQcDate': '2023-03-17', 'lastUpdatePostDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body mass index', 'timeFrame': '12 weeks', 'description': 'Body mass index is calculated as weight (kg)/\\[Height (m)\\^2\\]. Weight and height will be combined to report BMI in kg/m\\^2.'}], 'secondaryOutcomes': [{'measure': 'Body composition', 'timeFrame': '4 weeks and 12 weeks', 'description': 'Body composition including body fat percentage will be measured through body composition meter.'}, {'measure': 'The structure of gut microbiota', 'timeFrame': '4 weeks and 12 weeks', 'description': 'The 16s rRNA genes of fecal samples were analyzed.'}, {'measure': 'Height', 'timeFrame': '4 weeks and 12 weeks', 'description': 'The height is accurate to 0.1cm.'}, {'measure': 'Weight', 'timeFrame': '4 weeks and 12 weeks', 'description': 'The weight is accurate to 0.1kg.'}, {'measure': 'Waist circumference', 'timeFrame': '4 weeks and 12 weeks', 'description': 'The waist circumference is accurate to 0.1cm.'}, {'measure': 'Glycosylated hemoglobin level', 'timeFrame': '4 weeks and 12 weeks', 'description': 'The glycosylated hemoglobin is accurate to 0.1%.'}, {'measure': 'Fast triglyceride level', 'timeFrame': '4 weeks and 12 weeks', 'description': 'The fast triglyceride level will be measured by IMMULITE 1000 (Siemens,Germany).'}, {'measure': 'Fast total cholesterol level', 'timeFrame': '4 weeks and 12 weeks', 'description': 'The fast total cholesterol level will be measured by IMMULITE 1000 (Siemens,Germany).'}, {'measure': 'Fast low density lipoprotein level', 'timeFrame': '4 weeks and 12 weeks', 'description': 'The fast low density lipoprotein level will be measured by IMMULITE 1000 (Siemens,Germany).'}, {'measure': 'Fast high density lipoprotein level', 'timeFrame': '4 weeks and 12 weeks', 'description': 'The fast high density lipoprotein level will be measured by IMMULITE 1000 (Siemens,Germany).'}, {'measure': 'Defecation status', 'timeFrame': '4 weeks and 12 weeks', 'description': 'Care givers describe the defecation status in the past 1 week, including the frequency, nature, and color.'}, {'measure': 'Abdominal pain', 'timeFrame': '4 weeks and 12 weeks', 'description': 'Care givers describe whether abdominal pain occurs, and if so, provide frequency.'}, {'measure': 'Excessive flatulence', 'timeFrame': '4 weeks and 12 weeks', 'description': 'Care givers describe whether excessive flatulence occurs, and if so, provide frequency.'}, {'measure': 'Fast insulin level', 'timeFrame': '4 weeks and 12 weeks', 'description': 'The fast insulin level will be measured by IMMULITE 1000 (Siemens,Germany).'}, {'measure': 'Fast glucose level', 'timeFrame': '4 weeks and 12 weeks', 'description': 'The fast glucose level is detected by fingertip blood with blood glucose meter.'}, {'measure': 'Body mass index', 'timeFrame': '4 weeks', 'description': 'Body mass index is calculated as weight (kg)/\\[Height (m)\\^2\\]. Weight and height will be combined to report BMI in kg/m\\^2.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prader-Willi syndrome', 'Probiotics', 'Prebiotics'], 'conditions': ['Prader-Willi Syndrome']}, 'descriptionModule': {'briefSummary': 'Prader-Willi syndrome (PWS) is a rare genetic disease, with hyperappetite and severe obesity. At present, there is no effective drugs and interventions to help control the appetite of PWS patients. More and more evidence has shown that gut microbiota is closely related to obesity. Probiotics and prebiotics can improve the structure of gut microbiota, thus improve blood lipid levels and other biochemical indicators of obese people. Therefore, this study intends to explore the effectiveness and safety of probiotics and prebiotics in controlling appetite and weight gain of PWS children.', 'detailedDescription': 'Prader-Willi syndrome (PWS) is a rare genetic disease, with hyperappetite and severe obesity. Morbid obesity and related complications caused by hyperappetite are the most common causes of poor prognosis and death in PWS. At present, there is no effective drugs and interventions to help control the appetite of PWS patients. At present, more and more evidence has shown that gut microbiota is closely related to obesity. Probiotics and prebiotics can improve the structure of gut microbiota, thus improve blood lipid levels and other biochemical indicators of obese people. Therefore, this study intends to explore the effectiveness and safety of probiotics and prebiotics in controlling appetite and weight gain of PWS children. Participants will be divided into three groups, receiving probiotics, probiotics+probiotics or placebo treatment, and observe the changes in body weight, the structure of gut microbiota and metabolic level.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pre-adolescent children with Prader Willi syndrome which were definitely diagnosed by gene testing.\n* Consistent with the diagnostic criteria for obesity.\n* Not participate in other research projects at present or three months before the research;\n* Agree to participate in the test and obtain the consent of their parents; voluntarily be the subjects and sign the informed consent form.\n\nExclusion Criteria:\n\n* Losing weight in ways other than the intervention measures of this project, such as taking weight loss drugs or known drugs that cause weight change;\n* Use antibiotics within 1 month before the study and lasted for 3 days or more;\n* Use probiotics within 1 month before the study and lasted for 3 days or more;\n* Complicated with liver and renal insufficiency (alanine aminotransferase and serum creatinine indexes exceed 2 times the upper limit of the normal value set by the hospital);\n* Have gastrointestinal diseases affecting food digestion and absorption (such as severe diarrhea, constipation, severe gastrointestinal inflammation, active gastrointestinal ulcer, acute cholecystitis, etc.); severe diarrhea refers to watery stool 3 or more times a day and lasts for 3 or more days. severe constipation refers to defecation 2 or less times a week with difficulty in defecation;\n* Surgery was performed within 1 year before the study (except for appendicitis and hernia surgery);\n* Have hepatitis B, active tuberculosis, AIDS and other infectious diseases;\n* Those who are suffering from mental illness and are taking psychotropic drugs such as antidepressants.'}, 'identificationModule': {'nctId': 'NCT05791604', 'briefTitle': 'The Intervention of Obesity in Children With Prader-Willi Syndrome Using Prebiotics and Probiotics', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Fudan University"}, 'officialTitle': 'The Safety and Effectiveness Study of Prebiotics and Probiotics in the Intervention of Obesity in Children With Prader-Willi Syndrome', 'orgStudyIdInfo': {'id': 'PREPROPWS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotics group', 'description': 'Take probiotics during the study', 'interventionNames': ['Dietary Supplement: probiotics including B. lactis B420, B. lactis HN019, B. animalis Bb-12, L. rhamnosus GG']}, {'type': 'EXPERIMENTAL', 'label': 'Probiotics and prebiotics group', 'description': 'Take probiotics and prebiotics during the study', 'interventionNames': ['Dietary Supplement: probiotics including B. lactis B420, B. lactis HN019, B. animalis Bb-12, L. rhamnosus GG', 'Dietary Supplement: Prebiotics with galactomannan and oligofructose']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Take placebo food during the study'}], 'interventions': [{'name': 'probiotics including B. lactis B420, B. lactis HN019, B. animalis Bb-12, L. rhamnosus GG', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Take probiotics, 2g each time, twice a day, for 12 weeks', 'armGroupLabels': ['Probiotics and prebiotics group', 'Probiotics group']}, {'name': 'Prebiotics with galactomannan and oligofructose', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Take probiotics, 2g each time, twice a day, for 12 weeks Take prebiotics, 25g each time, twice a day, for 12 weeks', 'armGroupLabels': ['Probiotics and prebiotics group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Lui', 'role': 'CONTACT', 'email': 'wei_lu@fudan.edu.cn', 'phone': '86-021-64933281'}], 'facility': "Children's Hospital of Fudan University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Wei Lu, Dr', 'role': 'CONTACT', 'email': 'wei_lu@fudan.edu.cn', 'phone': '86-021-64933281'}], 'overallOfficials': [{'name': 'Wei Lu, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': "Children's Hospitial of Fudan Univeristy"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'After applying to the researcher, the researcher will decide whether to share the data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}