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Effects of Butyrate Enemas on Colonic Health

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ClinicalTrials.gov Identifier: NCT00693355
Recruitment Status : Completed
First Posted : June 9, 2008
Last Update Posted : February 24, 2017
Top Institute Food and Nutrition
Information provided by:
Maastricht University Medical Center

Brief Summary:

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).

Condition or disease Intervention/treatment Phase
Healthy Other: Sodium butyrate Other: NaCl Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Butyrate Enemas on Colonic Health
Study Start Date : December 2005
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Arm Intervention/treatment
Experimental: 1
sodium butyrate
Other: Sodium butyrate
sodium butyrate

Placebo Comparator: 2
Other: NaCl

Primary Outcome Measures :
  1. inflammatory parameters

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00693355

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University of Maastricht
Maastricht, Limburg, Netherlands, 6202MD
Sponsors and Collaborators
Maastricht University Medical Center
Top Institute Food and Nutrition
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Principal Investigator: Fred Troost, PhD Maastricht University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fred Troost, University of Maastricht
ClinicalTrials.gov Identifier: NCT00693355    
Other Study ID Numbers: MEC 05-137
First Posted: June 9, 2008    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017
Keywords provided by Maastricht University Medical Center:
gut health
Additional relevant MeSH terms:
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Butyric Acid
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs