Effects of Butyrate Enemas on Colonic Health

This study has been completed.
Sponsor:
Collaborator:
Top Institute Food and Nutrition
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00693355
First received: June 5, 2008
Last updated: June 6, 2008
Last verified: June 2008
  Purpose

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 Intervention
Healthy
Other: Sodium butyrate
Other: NaCl

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Butyrate Enemas on Colonic Health

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • inflammatory parameters [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: December 2005
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
sodium butyrate
Other: Sodium butyrate
sodium butyrate
Placebo Comparator: 2
NaCl
Other: NaCl
NaCl

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00693355

Locations
Netherlands
University of Maastricht
Maastricht, Limburg, Netherlands, 6202MD
Sponsors and Collaborators
Maastricht University
Top Institute Food and Nutrition
Investigators
Principal Investigator: Fred Troost, PhD Maastricht University
  More Information

No publications provided by Maastricht University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fred Troost, University of Maastricht
ClinicalTrials.gov Identifier: NCT00693355     History of Changes
Other Study ID Numbers: MEC 05-137
Study First Received: June 5, 2008
Last Updated: June 6, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
gut health

Additional relevant MeSH terms:
Butyric Acid
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014