Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-02-02 @ 7:02 AM
Study NCT ID:
NCT03707002
Status:
COMPLETED
Last Update Posted:
2018-10-16
First Post:
2018-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of scFOS on Increase in Stool Frequency in Constipated People
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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Identical sachets containing 5g of scFOS or placebo (maltodextrins)'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 186}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-15', 'studyFirstSubmitDate': '2018-10-05', 'studyFirstSubmitQcDate': '2018-10-15', 'lastUpdatePostDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Heart rate', 'timeFrame': 'at baseline and at the last visit (after 6 weeks)', 'description': 'heart rate (bit per minute)'}, {'measure': 'systolic blood pressure', 'timeFrame': 'at baseline and at the last visit (after 6 weeks)', 'description': 'systolic blood pressure (mmHg)'}, {'measure': 'diastolic blood pressure', 'timeFrame': 'at baseline and at the last visit (after 6 weeks)', 'description': 'diastolic blood pressure (mmHg)'}, {'measure': 'Adverse event', 'timeFrame': '6 weeks', 'description': 'Registration of all adverse events (number and severity of events)'}], 'primaryOutcomes': [{'measure': 'Stool frequency', 'timeFrame': '6 weeks', 'description': 'Change in the number of stool per week between week at Baseline and the last week of supplementation'}], 'secondaryOutcomes': [{'measure': 'Stool consistency', 'timeFrame': '6 weeks', 'description': 'Change in the stool consistency between Baseline and the end of supplementation, (Bristol Stool Scale 1 = hard to 7 = watery)'}, {'measure': 'Frequency and severity of Gastrointestinal symptoms', 'timeFrame': '6 weeks', 'description': 'Change in the frequency (number of occurrence) and severity (Likert scores from 0= no symptom to 7 =severe symptoms) individual Gastro-Intestinal symptoms (bloating, abdominal pain, flatulence,...) between Baseline and the end of supplementation'}, {'measure': 'Anxiety and depression', 'timeFrame': '6 weeks', 'description': 'Changes in anxiety and depression score between Baseline and the end of supplementation, measured by HAD score (Zigmond et al, 1983, from 0 to 21, score above 11 = anxiety or depression related pathology'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Functional Constipation', 'Healthy']}, 'descriptionModule': {'briefSummary': 'The study aims to evaluate the effects of short-chain fructo-oligosaccharides on the frequency and consistency of stools in subjects with functional constipation.', 'detailedDescription': 'This randomized, placebo-controlled, double-blind study aims to evaluate the effects of short-chain fructo-oligosaccharides on the frequency and consistency 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* functional constipation according to ROME III criteria with 3 or less than 3 stools per week\n* BMI between 18 and 32kg/m², limits included\n* Subjects who do not usually eat high-fibre foods\n* Subjects who do not usually consume foods siad "reduced in sugars" or "light"\n* Subjects who do not consume regularly pre- and probiotics in the form of dietary supplements\n\nExclusion Criteria:\n\n* subjects presenting Irritable bowel syndrome\n* history of chronic GI disorders: crohn disease, ulcerative colitis,....\n* treatments likely to influence GI sensitivity or motility (laxative, neuroleptics,...)\n* Antibiotic therapy in progress or in the past 8 weeks\n* medical history with impact on the study objectives as defined by investigator\n* known food allergy to one of the compounds of the study product'}, 'identificationModule': {'nctId': 'NCT03707002', 'acronym': 'CONSYST', 'briefTitle': 'Effect of scFOS on Increase in Stool Frequency in Constipated People', 'organization': {'class': 'INDUSTRY', 'fullName': 'Syral'}, 'officialTitle': 'Randomized, Placebo-controlled Double Blind Study to Evaluate the Effects of Dietary Supplementation With Short-chain Fructo-oligosaccharides (scFOS) on Nincrease in Stool Frequency in Constipated People', 'orgStudyIdInfo': {'id': 'PEC14513'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'scFOS', 'description': 'scFOS consumed at 5g/day for 6 weeks', 'interventionNames': ['Dietary Supplement: scFOS']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'maltodextrin consumed at 5g/day for 6 weeks', 'interventionNames': ['Dietary Supplement: Maltodextrin']}], 'interventions': [{'name': 'scFOS', 'type': 'DIETARY_SUPPLEMENT', 'description': 'daily intake for 6 weeks', 'armGroupLabels': ['scFOS']}, {'name': 'Maltodextrin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'daily intake for 6 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44800', 'city': 'Saint-Herblain', 'country': 'France', 'facility': 'Biofortis SAS', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}], 'overallOfficials': [{'name': 'David Gendre, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BioFortis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Syral', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Biofortis Mérieux NutriSciences', 'class': 'OTHER'}, {'name': 'CreaBio Rhone-Alpes', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}