Effects of Butyrate Enemas on Colonic Health

February 22, 2017 updated by: Maastricht University Medical Center

Short chain fatty acids (mainly acetate, propionate and butyrate) are produced in the large intestine by bacterial fermentation of unabsorbed carbohydrates, such as dietary fibers. Mainly butyrate is an important energy source of the mucosa and has a pivotal role in the regulation of mucosal proliferation, immune function and mucosal protection.

High fiber diets increase the concentrations of colonic butyrate, what has often been proposed as one of its protective mechanisms. Furthermore, butyrate enemas have been proved effective in the treatment of ulcerative colitis. In the present study the direct effects of butyrate on the distal colon will be studied in 30 healthy volunteers using rectal enemas. The study has been divided into two parts, each part studying different parameters, which interfere when measured synchronously and, therefore, need to be studied separately.

A. The effects of butyrate enemas on colonic permeability (n=15) B. The effects of butyrate enemas on parameters of colonic defense, integrity and inflammation (n=15) The effects of butyrate will be studied in a healthy and in a stressed colon. This way the protective effects of butyrate on intestinal stress can be studied. Prior to the main study, two small pilot studies will be carried out. In the first pilot study the retrograde spread of a rectal enema will investigated (n=2). In the second pilot study the dose and the type of a suitable stressor that will induce reversible damage to intestinal mucosa will be determined (n=12).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 18 and 60 years old
  • Good medical health according to a standard medical questionnaire
  • Regular defecation pattern (at least once daily)

Exclusion Criteria:

  • Use of medication other than oral anticonceptives
  • Calcium supplementation (during the study)
  • Caloric restriction diet (during the study)
  • Excessive drinking (>2 alcoholic consumptions a day)
  • Drug abuse in the past six months and during the study
  • Infectious disease (1 month prior to the study)
  • Pregnant or lactating women
  • Problems with urinary tract
  • History of gastrointestinal complaints or disease(s)

Study Plan

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

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
sodium butyrate
Other: Sodium butyrate
sodium butyrate
Placebo Comparator: 2
NaCl
Other: NaCl
NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
inflammatory parameters

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

Top Institute Food and Nutrition

Investigators

  • Principal Investigator: Fred Troost, PhD, Maastricht University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

June 5, 2008

First Submitted That Met QC Criteria

June 6, 2008

First Posted (Estimate)

June 9, 2008

Study Record Updates

Last Update Posted (Actual)

February 24, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC 05-137

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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