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

This study has been completed.
Sponsor:
Collaborator:
Top Institute Food and Nutrition
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00696098
First received: June 9, 2008
Last updated: October 6, 2009
Last verified: October 2009
  Purpose

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 Intervention
Gut Health
Other: sodium butyrate
Other: NaCl

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

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • inflammatory parameters [ Time Frame: okt 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • oxidative stress parameters [ Time Frame: okt 2008 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: May 2007
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696098

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

No publications provided

Responsible Party: Fred Troost, University of Maastricht
ClinicalTrials.gov Identifier: NCT00696098     History of Changes
Other Study ID Numbers: 06-3-067
Study First Received: June 9, 2008
Last Updated: October 6, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
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 20, 2014