Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-02-22 @ 7:23 PM
Study NCT ID:
NCT02786160
Status:
COMPLETED
Last Update Posted:
2018-12-13
First Post:
2016-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of HMOs on the Faecal Microbiota and on Host Metabolism in Obese Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006279', 'term': 'Health Maintenance Organizations'}], 'ancestors': [{'id': 'D008329', 'term': 'Managed Care Programs'}, {'id': 'D007348', 'term': 'Insurance, Health'}, {'id': 'D007341', 'term': 'Insurance'}, {'id': 'D005381', 'term': 'Financing, Organized'}, {'id': 'D004467', 'term': 'Economics'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D017061', 'term': 'Prepaid Health Plans'}, {'id': 'D006123', 'term': 'Group Practice'}, {'id': 'D011364', 'term': 'Professional Practice'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-11', 'studyFirstSubmitDate': '2016-05-23', 'studyFirstSubmitQcDate': '2016-05-25', 'lastUpdatePostDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in faecal microbiota profile', 'timeFrame': 'Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in clinical chemistry', 'timeFrame': 'Baseline and after 8 weeks of intake, and after 10 months of wash-out'}, {'measure': 'Change from baseline in haematology', 'timeFrame': 'Baseline and after 8 weeks of intake, and after 10 months of wash-out'}, {'measure': 'Change from baseline in gastrointestinal symptoms measured via the gastrointestinal symptom rating scale (GSRS)', 'timeFrame': 'Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out'}, {'measure': 'Change from baseline in Bristol Stool Form Scale (BSFS)', 'timeFrame': 'Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out'}, {'measure': 'Change from baseline in specific host-bacteria metabolic biomarkers in blood', 'timeFrame': 'Baseline and after 8 weeks of intake, and after 10 months of wash-out'}, {'measure': 'Change from baseline of HOMA-IR', 'timeFrame': 'Baseline and after 8 weeks of intake, and after 10 months of wash-out'}, {'measure': 'Change from baseline of BMI-SDS', 'timeFrame': 'Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out'}, {'measure': 'Change from baseline of fat percentage', 'timeFrame': 'Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out'}, {'measure': 'Change from baseline of waist circumference', 'timeFrame': 'Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out'}, {'measure': 'Change from baseline of hip circumference', 'timeFrame': 'Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out'}, {'measure': 'Change from baseline of specific blood biomarkers related to gut barrier function', 'timeFrame': 'Baseline and after 8 weeks of intake, and after 10 months of wash-out'}, {'measure': 'Change from baseline of specific blood biomarkers related to inflammation', 'timeFrame': 'Baseline and after 8 weeks of intake, and after 10 months of wash-out'}, {'measure': 'Change from baseline of specific faecal biomarkers related to inflammation', 'timeFrame': 'Baseline and after 8 weeks of intake, and after 10 months of wash-out'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '34139746', 'type': 'DERIVED', 'citation': 'Fonvig CE, Amundsen ID, Vigsnaes LK, Sorensen N, Frithioff-Bojsoe C, Christiansen M, Hedley PL, Holm LA, McConnell B, Holm JC. Human Milk Oligosaccharides Modulate Fecal Microbiota and Are Safe for Use in Children With Overweight: A Randomized Controlled Trial. J Pediatr Gastroenterol Nutr. 2021 Sep 1;73(3):408-414. doi: 10.1097/MPG.0000000000003205.'}]}, 'descriptionModule': {'briefSummary': 'The study is a randomised, placebo-controlled, double-blind, parallel study in obese children. A total of 75 obese children in the age 5 to 10 years, enrolled in a childhood obesity treatment program, will be included. The participating children will be randomised into one of three groups consuming either HMO (two groups) or placebo (one group).\n\nThe primary objective of the study is to establish the effects of HMOs on the faecal microbiota in children. Secondary objectives are to evaluate safety of HMO supplementation in children and the effect on gastrointestinal symptoms (tolerance), bowel habits, metabolic profile and body composition in obese children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Informed, written consent by the child's representative(s) and informed verbal assent by the child\n2. Age ≥5 and \\<11 years at visit 0\n3. BMI SDS of ≥ 2.3\n4. Enrolment in the childhood obesity treatment program at the Children's Obesity Clinic\n5. Ability and willingness to understand and comply with the study procedures\n6. The child's representative(s) need(s) to read, speak and understand Danish\n\nExclusion Criteria:\n\n1. Participation in another clinical intervention study one month prior to the screening visit and throughout the study.\n2. Any gastrointestinal disease(s) that may cause symptoms or may interfere with the trial outcome, as judged by the investigator.\n3. Other severe disease(s) such as malignancy, kidney disease or neurological disease, as judged by the investigator.\n4. Psychiatric disease, as judged by the investigator.\n5. Use of probiotic supplements (yoghurt allowed) 3 months prior to screening and throughout the study.\n6. Consumption of antibiotic drugs 3 months prior to screening and throughout the study.\n7. Consumption on a regular basis of medication that might interfere with symptom evaluation (as judged by the investigator) 2 weeks prior to screening and throughout the study.\n8. Lack of suitability for participation in the study for any reason as judged by the investigator."}, 'identificationModule': {'nctId': 'NCT02786160', 'briefTitle': 'Effects of HMOs on the Faecal Microbiota and on Host Metabolism in Obese Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Glycom A/S'}, 'officialTitle': 'The Effects of Human Milk Oligosaccharides (HMO) on the Faecal Microbiota and on Host Metabolism in Obese Children: A Parallel, Double-blind, Randomized, Placebo-controlled Study', 'orgStudyIdInfo': {'id': 'NATROB'}, 'secondaryIdInfos': [{'id': 'SJ-528', 'type': 'OTHER', 'domain': 'Den Videnskabsetiske Komité for Region Sjaelland'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'HMO1', 'description': 'Daily bolus of HMO1', 'interventionNames': ['Dietary Supplement: HMO']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HMO2', 'description': 'Daily bolus of HMO2', 'interventionNames': ['Dietary Supplement: HMO']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Dextropur', 'description': 'Daily bolus of Dextropur', 'interventionNames': ['Dietary Supplement: Dextropur']}], 'interventions': [{'name': 'HMO', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['HMO1', 'HMO2']}, {'name': 'Dextropur', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Dextropur']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4300', 'city': 'Holbæk', 'country': 'Denmark', 'facility': 'Department of Paediatrics, Holbaek Hospital', 'geoPoint': {'lat': 55.7175, 'lon': 11.71279}}], 'overallOfficials': [{'name': 'Jens-Christian Holm, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Holbaek Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glycom A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}