Rapid Orocecal Transit Time and Fermentation in IBS.

Oro-cecal Transit Time Clinical Trial

— RapidoIBS  

Official title:

Orocecal Transit Time and Fermentation in IBS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03141268
• Other study ID #: Orocecal lactulose breath
• Status: Recruiting
• Start date: January 1, 2017
• Est. completion date: July 1, 2019

Study information

• Verified date: August 2018
• Source: Uppsala University
• Contact: Per M Hellstrom, MD, PhD
• Phone: +46703727423
• Email: Per.Hellstrom[@]medsci.uu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Oro-cecal Transit Time

Intervention

Diagnostic Test:
• Lactulose breath test
Lactulose 0.67 mg/mL, dose 15 mL (10 grams). No contaminants of lactose. Pharmacy quality.

Locations

Country	Name	City	State
Sweden	Uppsala University	Uppsala	Uppsala County

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Orocecal transit time	The transit rate of lactulose (foods) through the small intestine	0-240 minutes
Secondary	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