Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2026-01-04 @ 7:05 AM
Study NCT ID:
NCT03141268
Status:
UNKNOWN
Last Update Posted:
2018-08-09
First Post:
2017-04-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rapid Orocecal Transit Time and Fermentation in IBS.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-07', 'studyFirstSubmitDate': '2017-04-03', 'studyFirstSubmitQcDate': '2017-05-02', 'lastUpdatePostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Orocecal transit time', 'timeFrame': '0-240 minutes', 'description': 'The transit rate of lactulose (foods) through the small intestine'}], 'secondaryOutcomes': [{'measure': 'Fermentation of lactulose of the cecal microbiota measured as increase of hydrogen in exhaled breath.', 'timeFrame': '0-240 minutes', 'description': 'The rise of hydrogen (beyond 10 and 20 ppm) after lactulose passing the ileo-cecal valve.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oro-cecal Transit Time']}, 'descriptionModule': {'briefSummary': 'Orocecal transit time is studied in individuals with irritable bowel syndrome (IBS) of both the constipation-dominant, diarrhea-dominant, and mixed form using the lactulose hydrogen breath test for orocecal transit time through the gut. Data are compared to those of healthy volunteers. The peak value of fermentation as read by hydrogen levels is captured after passage of the orocecal segment in the colon. Comparison are made between IBS patients and healthy subjects as regards orocecal transit time and peak fermentation in the cecum.', 'detailedDescription': 'Patients with IBS of various kind (constipation-dominant, diarrhea-dominant, and mixed form) in large numbers are studied as regards orocecal transit time and compared to healthy controls.\n\nInclusion criteria: IBS patients 18-80 years old, diagnosis of IBS; exclusion: Severe cardiac, pulmonary, liver or kidney disease, bloody stool After fasting for 12 hours, all subjects ingest 10 grams of lactulose. Hydrogen production, measured as hydrogen concentration in breath, is estimated at 10-minute intervals for a period of 240 minutes. The orocecal transit transit time is measured from ingestion of the lactulose solution until hydrogen peaks to 10 and 20 ppm when passing the ileocecal valve, being fermented by the cecal microflora. Data are compared to those of healthy volunteers.\n\nThe peak value of fermentation as read by hydrogen levels (ppm) captured after passage of the ilecocecal valve orocecal valve signifies the gas production of the micro13flora. Comparison are made between IBS patients and healthy subjects as regards orocecal transit time and peak fermentation in the cecum.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'IBS patients aged 18-80 years of age as recruited in the clinic, some of which are lactose intolerant, others are lactose tolerant.\n\nHealthy volunteers 18-80 years of age as recruited in society in daily life activities.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects, or IBS patients or either kind (IBS-C, IBS-D, IBS-M), no concomitant medication.\n\nExclusion Criteria:\n\n* Chronic disease, such cardiac, pulmonary, liver, kidney, endocrinological rheumatological, neurological or psychiatric disease plus, in addition, chronic medication.'}, 'identificationModule': {'nctId': 'NCT03141268', 'acronym': 'RapidoIBS', 'briefTitle': 'Rapid Orocecal Transit Time and Fermentation in IBS.', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'Orocecal Transit Time and Fermentation in IBS', 'orgStudyIdInfo': {'id': 'Orocecal lactulose breath'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy volunteers', 'description': 'Normal subjects aged 18-80 years. No chronic diseases.', 'interventionNames': ['Diagnostic Test: Lactulose breath test']}, {'label': 'IBS patients, lactose intolerant', 'description': 'Subjects 18-80 years diagnosed with IBS for more than 6 months ago; lactose intolerant. No concomitant diseases.', 'interventionNames': ['Diagnostic Test: Lactulose breath test']}, {'label': 'IBS patients, lactose tolerant', 'description': 'Subjects 18-80 years diagnosed with IBS for more than 6 months ago; lactose tolerant. No concomitant diseases.', 'interventionNames': ['Diagnostic Test: Lactulose breath test']}], 'interventions': [{'name': 'Lactulose breath test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Lactulose 0.67 mg/mL, dose 15 mL (10 grams). No contaminants of lactose. Pharmacy quality.', 'armGroupLabels': ['Healthy volunteers', 'IBS patients, lactose intolerant', 'IBS patients, lactose tolerant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75185', 'city': 'Uppsala', 'state': 'Uppsala County', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Per M Hellstrom, MD, Prof', 'role': 'CONTACT', 'email': 'Per.Hellstrom@medsci.uu.se', 'phone': '+46 70 3727423'}, {'name': 'Dominic-Luc Webb, PhD', 'role': 'CONTACT', 'email': 'Dominic-Luc.Webb@medsci.uu.se', 'phone': '+46 18 4714721'}, {'name': 'Per M Hellström, MD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Uppsala University', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'centralContacts': [{'name': 'Per M Hellstrom, MD, PhD', 'role': 'CONTACT', 'email': 'Per.Hellstrom@medsci.uu.se', 'phone': '+46703727423'}, {'name': 'Peter Benno, MD, PhD', 'role': 'CONTACT', 'email': 'Peter.Benno@endoskopienheten.se', 'phone': '+46705795554'}], 'overallOfficials': [{'name': 'Per M Hellstrom, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uppsala University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data are freely available to anyone. Data coded.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Per Hellström', 'investigatorAffiliation': 'Uppsala University'}}}}