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

NCT ID: NCT00696098

Last Updated: 2017-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2009-10-31

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.

Conditions

Gut Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

1

sodium butyrate

Group Type: EXPERIMENTAL

sodium butyrate

Intervention Type: OTHER

1 enema (60 ml) once daily containing 100mM

2

Group Type: PLACEBO_COMPARATOR

NaCl

Intervention Type: OTHER

1 enema (60 ml) once daily containing 0.9%NaCl

Interventions

sodium butyrate

1 enema (60 ml) once daily containing 100mM

Intervention Type: OTHER

NaCl

1 enema (60 ml) once daily containing 0.9%NaCl

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Top Institute Food and Nutrition

OTHER

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

University of Maastricht

Principal Investigators

Fred Troost, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Locations

University of Maastricht

Maastricht, Limburg, Netherlands

Countries

Netherlands

Other Identifiers

06-3-067

Identifier Type: -

Identifier Source: org_study_id