Rapid Orocecal Transit Time and Fermentation in IBS. (RapidoIBS)

Orocecal Transit Time and Fermentation in IBS

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.

Study Overview

• Status: Unknown
• Conditions: Oro-cecal Transit Time
• Intervention / Treatment: Diagnostic test: Lactulose breath test

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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• Sweden
  • Uppsala County
    • Uppsala, Uppsala County, Sweden, 75185
      • Recruiting
      • Uppsala University
      • Contact: Per M Hellstrom, MD, Prof; Phone Number: +46 70 3727423; Email: Per.Hellstrom@medsci.uu.se
      • Contact: Dominic-Luc Webb, PhD; Phone Number: +46 18 4714721; Email: Dominic-Luc.Webb@medsci.uu.se
      • Principal Investigator: Per M Hellström, MD, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy volunteers; Normal subjects aged 18-80 years. No chronic diseases.	Diagnostic test: Lactulose breath test; Lactulose 0.67 mg/mL, dose 15 mL (10 grams). No contaminants of lactose. Pharmacy quality.
IBS patients, lactose intolerant; Subjects 18-80 years diagnosed with IBS for more than 6 months ago; lactose intolerant. No concomitant diseases.	Diagnostic test: Lactulose breath test; Lactulose 0.67 mg/mL, dose 15 mL (10 grams). No contaminants of lactose. Pharmacy quality.
IBS patients, lactose tolerant; Subjects 18-80 years diagnosed with IBS for more than 6 months ago; lactose tolerant. No concomitant diseases.	Diagnostic test: Lactulose breath test; Lactulose 0.67 mg/mL, dose 15 mL (10 grams). No contaminants of lactose. Pharmacy quality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Orocecal transit time	The transit rate of lactulose (foods) through the small intestine	0-240 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Uppsala University
• Investigators: Principal Investigator: Per M Hellström, MD, PhD, Uppsala University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: April 3, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (Actual): May 5, 2017

Study Record Updates

• Last Update Posted (Actual): August 9, 2018
• Last Update Submitted That Met QC Criteria: August 7, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Agents; Lactulose
• Other Study ID Numbers: Orocecal lactulose breath

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data are freely available to anyone. Data coded.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No