We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00696098
Recruitment Status : Completed
First Posted : June 12, 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 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.

Condition or disease Intervention/treatment Phase
Gut Health Other: sodium butyrate Other: NaCl Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Butyrate on Colonic Health of Patients With Diarrhoea Predominant
Study Start Date : May 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Experimental: 1
sodium butyrate
Other: sodium butyrate
1 enema (60 ml) once daily containing 100mM

Placebo Comparator: 2 Other: NaCl
1 enema (60 ml) once daily containing 0.9%NaCl

Primary Outcome Measures :
  1. inflammatory parameters [ Time Frame: okt 2008 ]

Secondary Outcome Measures :
  1. oxidative stress parameters [ Time Frame: okt 2008 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00696098

Layout table for location information
University of Maastricht
Maastricht, Limburg, Netherlands, 6202 MD
Sponsors and Collaborators
Maastricht University Medical Center
Top Institute Food and Nutrition
Layout table for investigator information
Principal Investigator: Fred Troost, PhD Maastricht University
Layout table for additonal information
Responsible Party: Fred Troost, University of Maastricht
ClinicalTrials.gov Identifier: NCT00696098    
Other Study ID Numbers: 06-3-067
First Posted: June 12, 2008    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: October 2009
Additional relevant MeSH terms:
Layout table for MeSH terms
Signs and Symptoms, Digestive
Butyric Acid
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs