Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2026-04-22 @ 1:21 AM
Study NCT ID:
NCT02270268
Status:
COMPLETED
Last Update Posted:
2016-03-24
First Post:
2014-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Pectin Supplementation in Diarrhea-predominant 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': 'D010368', 'term': 'Pectins'}, {'id': 'C008315', 'term': 'maltodextrin'}], 'ancestors': [{'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010936', 'term': 'Plant Extracts'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-23', 'studyFirstSubmitDate': '2014-10-10', 'studyFirstSubmitQcDate': '2014-10-17', 'lastUpdatePostDateStruct': {'date': '2016-03-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'efficacy: change of stool frequency, faecal form and clinical symptoms score', 'timeFrame': 'six weeks after inclusion', 'description': 'change from baseline in stool frequency, faecal form (Bristol stool scale) and clinical symptoms score (7-point Likert scale) at six weeks'}], 'secondaryOutcomes': [{'measure': 'efficacy: gut microbiota', 'timeFrame': 'six weeks after inclusion', 'description': 'real-time PCR'}, {'measure': 'efficacy: cytokine ratios', 'timeFrame': 'six weeks after inclusion', 'description': 'Cytokine production'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Irritable bowel syndrome', 'Gut microbiota', 'Soluble dietary fiber'], 'conditions': ['Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of pectin, a kind of soluble dietary fiber, on clinical symptoms, gut microbiota and the immune status in patients with diarrhea-predominant irritable bowel syndrome', 'detailedDescription': 'Patients were randomized to receive either pectin or placebo. Treatment consisted of 6 weeks supplementation with pectin (fiber group) or placebo (maltodextrin). We evaluated the clinical symptoms, gut microbiota and the immune markers in two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients(age≧18y)\n* Admitted for diarrhea-predominant irritable bowel syndrome\n\nExclusion Criteria:\n\n* Mental disorders\n* Cancer\n* Inflammatory bowel disease'}, 'identificationModule': {'nctId': 'NCT02270268', 'briefTitle': 'Effects of Pectin Supplementation in Diarrhea-predominant Irritable Bowel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing PLA General Hospital'}, 'officialTitle': 'Therapeutic Effects of Pectin Supplementation in Patients With Diarrhea-predominant Irritable Bowel Syndrome', 'orgStudyIdInfo': {'id': '2011NLY073'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pectin', 'description': 'a kind of soluble dietary fiber', 'interventionNames': ['Dietary Supplement: Pectin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'maltodextrin', 'interventionNames': ['Dietary Supplement: maltodextrin']}], 'interventions': [{'name': 'Pectin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Pectin （Andeli Ltd. Yantai, China）, 24g/d for six weeks', 'armGroupLabels': ['pectin']}, {'name': 'maltodextrin', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Tao Gao, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanjing PLA General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nanjing PLA General Hospital', 'investigatorFullName': 'Gao Tao', 'investigatorAffiliation': 'Nanjing PLA General Hospital'}}}}