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Completed

NCT Number: NCT00696098

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

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.

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Key information

Conditions

Gut Health

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maastricht

Maastricht, Limburg, 6202 MD, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sodium butyrate

Other

1 enema (60 ml) once daily containing 100mM

NaCl

Other

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

Primary outcomes

  1. inflammatory parameters

    Time frame: okt 2008

Secondary outcomes

  1. oxidative stress parameters

    Time frame: okt 2008

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Top Institute Food and Nutrition

Registry information

Official study title

Effects of Butyrate on Colonic Health of Patients With Diarrhoea Predominant

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jun 12, 2008
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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