Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT01613456
Status:
COMPLETED
Last Update Posted:
2015-05-14
First Post:
2012-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Saccharomyces Cerevisiae on the Symptoms of 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 364}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-13', 'studyFirstSubmitDate': '2012-06-05', 'studyFirstSubmitQcDate': '2012-06-06', 'lastUpdatePostDateStruct': {'date': '2015-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in discomfort score,obtained by Daily Likert Scale averaged by week', 'timeFrame': 'baseline and week 8'}]}, 'conditionsModule': {'conditions': ['Irritable Bowel Syndrome']}, 'referencesModule': {'references': [{'pmid': '27403301', 'type': 'DERIVED', 'citation': 'Spiller R, Pelerin F, Cayzeele Decherf A, Maudet C, Housez B, Cazaubiel M, Justen P. Randomized double blind placebo-controlled trial of Saccharomyces cerevisiae CNCM I-3856 in irritable bowel syndrome: improvement in abdominal pain and bloating in those with predominant constipation. United European Gastroenterol J. 2016 Jun;4(3):353-62. doi: 10.1177/2050640615602571. Epub 2015 Aug 21.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is the effect of the probiotic yeast Saccharomyces cerevisiae CNCM I-3856 on abdominal pain or intestinal discomfort in patients presenting with the irritable bowel syndrome (IBS)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* IBS subject meeting the Rome III criteria , with a discomfort or pain present more than 1 day per week in whom organic causes of their symptoms have been excluded\n* IBS-C with less than 3 complete spontaneous bowel movements/week\n* IBS-D with at least 2 or more days/week one stool which has consistency of type 6 or 7 Bristol stool score\n* Subject able of and willing to comply with the protocol and to give their written informed consents\n\nExclusion criteria:\n\n* History of chronic gastrointestinal disorders\n* History of lactose intolerance\n* History of gluten intolerance\n* Treatment able to influence IBS, modifying intestinal sensitivity and motility (antidepressants,opioid, narcotic analgesics)\n* Eating disorders\n* Pregnancy in progress'}, 'identificationModule': {'nctId': 'NCT01613456', 'briefTitle': 'Effect of Saccharomyces Cerevisiae on the Symptoms of Irritable Bowel Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lesaffre International'}, 'officialTitle': 'Effect of S.Cerevisiae vs Placebo on the Improvement of Gastrointestinal Disorders,Especially During Irritable Bowel Syndrome. Randomized, Double-blind Study', 'orgStudyIdInfo': {'id': 'PEC11010'}, 'secondaryIdInfos': [{'id': 'ID RCB: 2011-A00915-36', 'type': 'OTHER', 'domain': 'French Health Products Safety Agency'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Dicalcium phosphate, Maltodextrin and Magnesium stearate.', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Saccharomyces cerevisiae CNCM I-3856', 'interventionNames': ['Dietary Supplement: Saccharomyces cerevisiae CNCM I-3856']}], 'interventions': [{'name': 'Saccharomyces cerevisiae CNCM I-3856', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 capsules/day during 12 weeks', 'armGroupLabels': ['Saccharomyces cerevisiae CNCM I-3856']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Capsule with comparable organoleptic properties and weight than the experimental product.\n\n2 capsules/day during 12 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44800', 'city': 'Saint-Herblain', 'country': 'France', 'facility': 'Biofortis', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}], 'overallOfficials': [{'name': 'David GENDRE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BioFortis'}, {'name': 'Robin SPILLER, Professor of Gastroenterology', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nottingham Digestive Diseases Centre University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lesaffre International', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'BioFortis', 'class': 'OTHER'}, {'name': 'University of Nottingham', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}