Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2026-01-04 @ 3:36 AM
Study NCT ID:
NCT01847950
Status:
COMPLETED
Last Update Posted:
2018-10-05
First Post:
2012-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of scFOS on Stool Frequency in People With Functionnal Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C008315', 'term': 'maltodextrin'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-04', 'studyFirstSubmitDate': '2012-12-06', 'studyFirstSubmitQcDate': '2013-05-06', 'lastUpdatePostDateStruct': {'date': '2018-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Transit time', 'timeFrame': '6 weeks'}], 'primaryOutcomes': [{'measure': 'Frequency of stool emission', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Stool consistency (Bristol scale)', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Functional Constipation']}, 'descriptionModule': {'briefSummary': 'The study aims to evaluate the effects of short-chain fructo-oligosaccharides on the frequency and constistency of stools in subjects with functional constipation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects with functional constipation\n\nExclusion Criteria:\n\n* subjects treated with laxative treatments\n* subjects consuming more than 25g/day of dietary fibres\n* pregnant women'}, 'identificationModule': {'nctId': 'NCT01847950', 'briefTitle': 'Effects of scFOS on Stool Frequency in People With Functionnal Constipation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Syral'}, 'officialTitle': 'Randomized, Placebo-controlled Double-blind Study to Evaluate the Effects of Fructo-oligosachharides on Increase of Stool Frequency in Constipated People', 'orgStudyIdInfo': {'id': 'ConstiFOS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'short-chain fructo-oligosaccharides', 'description': 'Short-chain fructo-oligosaccharides are consummed at 5g/day for 6 weeks', 'interventionNames': ['Dietary Supplement: Short-chain fructo-oligosaccharides']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Maltodextrin', 'description': 'maltodextrins are consummed at 5g/day for 6 weeks', 'interventionNames': ['Dietary Supplement: Maltodextrin']}], 'interventions': [{'name': 'Short-chain fructo-oligosaccharides', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Short-chain fructo-oligosaccharides are consummed at 5g/day for 6 weeks', 'armGroupLabels': ['short-chain fructo-oligosaccharides']}, {'name': 'Maltodextrin', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Maltodextrin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93009', 'city': 'Bobigny', 'country': 'France', 'facility': 'CRNH-CRV Avicenne Hospital', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}], 'overallOfficials': [{'name': 'Robert Benamouzig, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CRNH - CRV Avicenne Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Syral', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}