Effects of Butyrate Enemas on Colonic Health

Healthy Clinical Trial

Official title:

Effects of Butyrate Enemas on Colonic Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00693355
• Other study ID #: MEC 05-137
• Status: Completed
• Phase: N/A
• First received: June 5, 2008
• Last updated: February 22, 2017
• Start date: December 2005
• Est. completion date: May 2008

Study information

• Verified date: February 2017
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Sodium butyrate
sodium butyrate
• NaCl
NaCl

Locations

Country	Name	City	State
Netherlands	University of Maastricht	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Top Institute Food and Nutrition

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inflammatory parameters