Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-25 @ 7:32 PM
Study NCT ID:
NCT01829932
Status:
COMPLETED
Last Update Posted:
2015-10-14
First Post:
2013-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Prebiotics on the Microbiome in Irritable Bowel Syndrome Patients: The Diet and Microbiome Study
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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-13', 'studyFirstSubmitDate': '2013-04-09', 'studyFirstSubmitQcDate': '2013-04-09', 'lastUpdatePostDateStruct': {'date': '2015-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the Curve of Hydrogen Gas on Lactulose Breath Test', 'timeFrame': '5 hours'}], 'secondaryOutcomes': [{'measure': 'Change in Area Under the Curve on Lactulose Breath Test from Baseline', 'timeFrame': '5 hours'}, {'measure': 'Change in IBS Symptom Severity Score from Baseline', 'timeFrame': '3 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diet'], 'conditions': ['Irritable Bowel Syndrome']}, 'referencesModule': {'references': [{'pmid': '26976734', 'type': 'DERIVED', 'citation': 'McIntosh K, Reed DE, Schneider T, Dang F, Keshteli AH, De Palma G, Madsen K, Bercik P, Vanner S. FODMAPs alter symptoms and the metabolome of patients with IBS: a randomised controlled trial. Gut. 2017 Jul;66(7):1241-1251. doi: 10.1136/gutjnl-2015-311339. Epub 2016 Mar 14.'}]}, 'descriptionModule': {'briefSummary': 'Irritable bowel syndrome (IBS) is a chronic gastrointestinal illness of unknown cause whose symptoms include abdominal pain, bloating and altered bowel pattern. Diet has been shown to influence the bacteria gut interaction. Our aim is to determine if components of the diet affect IBS symptoms by changing the bacteria gut interaction. In particular, we will measure whether after being on a diet high or low on certain factors there is a change in the timing and amount of hydrogen and methane produced by bacteria digesting lactulose and on IBS symptom severity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meet Rome III criteria for IBS\n* Willing to undergo dietary intervention\n\nExclusion Criteria:\n\n* History of Gastric, Small Bowel or Colonic Surgery\n* History of Inflammatory Bowel Disease\n* Celiac Disease\n* Unable to come off following medications: antibiotics, laxatives, narcotics, sedatives\n* On a pre specified diet\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT01829932', 'briefTitle': 'The Effect of Prebiotics on the Microbiome in Irritable Bowel Syndrome Patients: The Diet and Microbiome Study', 'organization': {'class': 'OTHER', 'fullName': "Queen's University"}, 'officialTitle': 'The Effect of Prebiotics on the Microbiome in Irritable Bowel Syndrome Patients: The Diet and Microbiome Study', 'orgStudyIdInfo': {'id': 'DMED-1443-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High Factor Diet', 'description': 'Patients will be on a factor altered diet to see effects on their lactulose breath test and symptoms.', 'interventionNames': ['Dietary Supplement: Factor Altered Diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low Factor Diet', 'description': 'Patients will be on a factor altered diet to assess its effects on symptoms and lactulose breath test.', 'interventionNames': ['Dietary Supplement: Factor Altered Diet']}], 'interventions': [{'name': 'Factor Altered Diet', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['High Factor Diet', 'Low Factor Diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K7L 5G2', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hotel Dieu Hospital', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}], 'overallOfficials': [{'name': 'Stephen Vanner, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Queen's University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Queen's University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Dr. Stephen Vanner', 'investigatorAffiliation': "Queen's University"}}}}