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

Effects of Butyrate on Colonic Health of Patients With Diarrhoea Predominant

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.

Study Overview

• Status: Completed
• Conditions: Gut Health
• Intervention / Treatment: Other: sodium butyrate; Other: NaCl

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6202 MD
      • University of Maastricht

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2	Other: NaCl; 1 enema (60 ml) once daily containing 0.9%NaCl
Experimental: 1; sodium butyrate	Other: sodium butyrate; 1 enema (60 ml) once daily containing 100mM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
inflammatory parameters	okt 2008

Secondary Outcome Measures

Outcome Measure	Time Frame
oxidative stress parameters	okt 2008

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Top Institute Food and Nutrition
• Investigators: Principal Investigator: Fred Troost, PhD, Maastricht University

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: June 9, 2008
• First Submitted That Met QC Criteria: June 9, 2008
• First Posted (Estimate): June 12, 2008

Study Record Updates

• Last Update Posted (Actual): February 24, 2017
• Last Update Submitted That Met QC Criteria: February 22, 2017
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Histamine Antagonists; Histamine Agents; Butyric Acid
• Other Study ID Numbers: 06-3-067