Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-01-01 @ 11:58 AM
Study NCT ID:
NCT00806104
Status:
COMPLETED
Last Update Posted:
2011-01-17
First Post:
2008-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fructo-oligosaccharides and Irritable Bowel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C116580', 'term': 'fructooligosaccharide'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-14', 'studyFirstSubmitDate': '2008-12-09', 'studyFirstSubmitQcDate': '2008-12-09', 'lastUpdatePostDateStruct': {'date': '2011-01-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rectal sensitivity', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'taxonomic composition of intestinal microbiota', 'timeFrame': '4 weeks'}]}, 'conditionsModule': {'conditions': ['Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': 'Fructo-oligosaccharides are known as prebiotic ingredients to modulate the composition of the intestinal microbiota and particularly to stimulate the growth of Bifidobacteria. Imbalance of the intestinal microbiota such as reduction of Bifidobacteria is implicated in Irritable Bowel Syndrome (IBS). Thus the objective of the study is to evaluate the effect of fructo-oligosaccharides to improve IBS score and to explore which modifications of the microbiota are responsible of this improvement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* IBS subjects according to Rome III criteria\n* Incomfort below or equivalent to 30mmHg during Tensostat test\n* between 18 and 60 years\n* no antibiotic treatment for the last 2 months\n* less than 20g of dietary fibres consummed per day\n* no analgesic treatment\n* no treatment for intestinal transit\n\nExclusion Criteria:\n\n* subjects suffering from diabetes, colic cancer, inflammatory bowel disease, dysthyroidy, Hirschprung disease, anorexia\n* excessive consumption of alcohol or tobacco\n* participating to another clinical study\n* pregnant women\n* antidepressor or anxiolytic treatment'}, 'identificationModule': {'nctId': 'NCT00806104', 'briefTitle': 'Fructo-oligosaccharides and Irritable Bowel Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beghin-Meiji'}, 'officialTitle': 'Effect of Dietary Supplementation With Fructo-oligosaccharides on Visceral Sensitivity and on Taxonomic and Functional Composition of Intestinal Microbiota of IBS Patients', 'orgStudyIdInfo': {'id': 'FOS_QLV2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Fructo-oligosaccharides', 'interventionNames': ['Dietary Supplement: Fructo-oligosaccharides']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Maltodextrins', 'interventionNames': ['Dietary Supplement: Maltodextrins']}], 'interventions': [{'name': 'Fructo-oligosaccharides', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Dietary supplementation for 4 weeks', 'armGroupLabels': ['1']}, {'name': 'Maltodextrins', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Dietary supplementation for 4 weeks', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Clermont Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Vall Hebron Hospital', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Michel Dapoigny, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beghin-Meiji', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Frederique Respondek / Scientific Affairs Manager', 'oldOrganization': 'Beghin Meiji'}}}}