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

NCT00696098 | Completed

• 1 other identifier: 06-3-067
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• inflammatory parameters

  okt 2008

Secondary Outcomes (1)

• oxidative stress parameters

  okt 2008

Study Arms (2)

1

EXPERIMENTAL

sodium butyrate

Other: sodium butyrate

2

PLACEBO COMPARATOR

Other: NaCl

Interventions

sodium butyrate OTHER

1 enema (60 ml) once daily containing 100mM

1

NaCl OTHER

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

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of UC or Diarrhea predominant IBS
• Stable western diet
• Age between 18 and 65
• BMI between 18 and 35
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Top Institute Food and Nutrition: collaborator

Study Sites (1)

University of Maastricht

Maastricht, Limburg, 6202 MD, Netherlands

Location

MeSH Terms

Interventions

Butyric Acid

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Fred Troost, PhD

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 9, 2008
• First Posted: June 12, 2008
• Study Start: May 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: October 1, 2009
• Last Updated: February 24, 2017

Record last verified: 2009-10

Locations

NL (1)