Rapid Orocecal Transit Time and Fermentation in IBS.
RapidoIBS
Orocecal Transit Time and Fermentation in IBS
1 other identifier
observational
1,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
April 3, 2017
CompletedFirst Posted
Study publicly available on registry
May 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedAugust 9, 2018
August 1, 2018
2.5 years
April 3, 2017
August 7, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Orocecal transit time
The transit rate of lactulose (foods) through the small intestine
0-240 minutes
Secondary Outcomes (1)
Fermentation of lactulose of the cecal microbiota measured as increase of hydrogen in exhaled breath.
0-240 minutes
Study Arms (3)
Healthy volunteers
Normal subjects aged 18-80 years. No chronic diseases.
IBS patients, lactose intolerant
Subjects 18-80 years diagnosed with IBS for more than 6 months ago; lactose intolerant. No concomitant diseases.
IBS patients, lactose tolerant
Subjects 18-80 years diagnosed with IBS for more than 6 months ago; lactose tolerant. No concomitant diseases.
Interventions
Lactulose 0.67 mg/mL, dose 15 mL (10 grams). No contaminants of lactose. Pharmacy quality.
Eligibility Criteria
IBS patients aged 18-80 years of age as recruited in the clinic, some of which are lactose intolerant, others are lactose tolerant. Healthy volunteers 18-80 years of age as recruited in society in daily life activities.
You may qualify if:
- Healthy subjects, or IBS patients or either kind (IBS-C, IBS-D, IBS-M), no concomitant medication.
You may not qualify if:
- Chronic disease, such cardiac, pulmonary, liver, kidney, endocrinological rheumatological, neurological or psychiatric disease plus, in addition, chronic medication.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Uppsala University
Uppsala, Uppsala County, 75185, Sweden
Study Officials
- PRINCIPAL INVESTIGATOR
Per M Hellstrom, MD, PhD
Uppsala University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 3, 2017
First Posted
May 5, 2017
Study Start
January 1, 2017
Primary Completion
July 1, 2019
Study Completion
July 1, 2019
Last Updated
August 9, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will share
Data are freely available to anyone. Data coded.