Effects of Butyrate on Colonic Health of Patients With Diarrhoea Predominant IBS and UC in Remission

Not Applicable

Completed

• Conditions: Gut Health
• Interventions: Other: sodium butyrate; Other: NaCl

• Registration Number: NCT00696098
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2008-06-09
• Study First Submitted QC: 2008-06-09
• Study First Posted: 2008-06-12
• Primary Completion: 2009-09
• Status Verified: 2009-10
• Study Completion: 2009-10
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Clinical diagnosis of UC or Diarrhea predominant IBS
• Stable western diet
• Age between 18 and 65
• BMI between 18 and 35
• Written informed consent

Exclusion Criteria

• 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
• Changes in medication during or 1 month prior to the study
• Lactation, pregnancy and planning of pregnancy
• Previous intestinal surgery
• Clinically significant systemic diseases
• Excessive drinking (>20 alcoholic consumptions per week)
• Changes in prebiotic and/or probiotic use during and 2 weeks prior to the study
• Previous radiotherapy or chemotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	sodium butyrate	sodium butyrate
2	NaCl	-

Primary Outcome Measures

Name	Time	Method
inflammatory parameters	okt 2008

Secondary Outcome Measures

Name	Time	Method
oxidative stress parameters	okt 2008

Trial Locations

Locations (1)

University of Maastricht; 🇳🇱 Maastricht, Limburg, Netherlands