Rapid Orocecal Transit Time and Fermentation in IBS.

• Conditions: Oro-cecal Transit Time
• Interventions: Diagnostic Test: Lactulose breath test

• Registration Number: NCT03141268
• Lead Sponsor: Uppsala University

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.

Detailed Description

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.

Inclusion 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.

The 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.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-04-03
• Study First Submitted QC: 2017-05-02
• Study First Posted: 2017-05-05
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-09
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Healthy subjects, or IBS patients or either kind (IBS-C, IBS-D, IBS-M), no concomitant medication.

Exclusion Criteria

• Chronic disease, such cardiac, pulmonary, liver, kidney, endocrinological rheumatological, neurological or psychiatric disease plus, in addition, chronic medication.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Lactulose breath test	Normal subjects aged 18-80 years. No chronic diseases.
IBS patients, lactose intolerant	Lactulose breath test	Subjects 18-80 years diagnosed with IBS for more than 6 months ago; lactose intolerant. No concomitant diseases.
IBS patients, lactose tolerant	Lactulose breath test	Subjects 18-80 years diagnosed with IBS for more than 6 months ago; lactose tolerant. No concomitant diseases.

Primary Outcome Measures

Name	Time	Method
Orocecal transit time	0-240 minutes	The transit rate of lactulose (foods) through the small intestine

Secondary Outcome Measures

Name	Time	Method
Fermentation of lactulose of the cecal microbiota measured as increase of hydrogen in exhaled breath.	0-240 minutes	The rise of hydrogen (beyond 10 and 20 ppm) after lactulose passing the ileo-cecal valve.

Trial Locations

Locations (1)

Uppsala University; 🇸🇪 Uppsala, Uppsala County, Sweden