Completed

Effects of Butyrate on Colonic Health of Patients With Diarrhoea Predominant

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What is being tested

sodium butyrate

+ NaCl

Other
Who is being recruted

From 18 to 65 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Placebo-Controlled
Interventional
Study Start: May 2007
See protocol details

Summary

Principal SponsorMaastricht University Medical Center
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2007

Actual date on which the first participant was enrolled.

Short chain fatty acids (mainly butyrate, acetate, and propionate) are produced in the large intestine by bacterial fermentation of undigested carbohydrates, such as dietary fibres. Butyrate is an important energy source of the intestinal epithelium and has a pivotal role in the regulation of epithelial cell proliferation and differentiation, immune function and mucosal protection. Non-digestible carbohydrates (prebiotics) increase the concentrations of colonic butyrate, which has been proposed to be responsible for its beneficial effects. Furthermore, butyrate enemas have been proven to be effective in the treatment of active ulcerative colitis. In the present study, the direct effects of butyrate on inflammation and parameters of colonic defence and mucosal integrity of the distal colon will be studied in 40 patients with diarrhoea predominant IBS (D-IBS) and 40 patients with ulcerative colitis in remission (UCrem) using rectal enemas. These patients groups were chosen because they have a low-grade inflammation in the large intestine, and can therefore be used as a model to study the mechanistic effects of butyrate. The design used to study the effects of butyrate in both patient groups will be a double blind randomized placebo-controlled parallel design.

Official TitleEffects of Butyrate on Colonic Health of Patients With Diarrhoea Predominant
NCT00696098
Principal SponsorMaastricht University Medical Center
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
Clinical diagnosis of UC or Diarrhea predominant IBS

Stable western diet

Age between 18 and 65

BMI between 18 and 35

Show More Criteria

11 exclusion criteria prevent from participating
All enemas and suppository during or 2 weeks prior to the study

Use of corticosteroids during or 1 month prior to the study

Use of antibiotics during or 3 months prior to the study

Budesonide during or 2 weeks prior to the study

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
sodium butyrate

Group II

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Maastricht

Maastricht, NetherlandsOpen University of Maastricht in Google Maps
CompletedOne Study Center