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

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Butyrate on Colonic Health of Patients With Diarrhoea Predominant

Conditions
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Gut Health

Intervention / Treatment
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* Other: sodium butyrate
* Other: NaCl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>sodium butyrate | Other: sodium butyrate<br>* 1 enema (60 ml) once daily containing 100mM<br>|
| Placebo Comparator: 2<br> | Other: NaCl<br>* 1 enema (60 ml) once daily containing 0.9%NaCl<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammatory parameters |  | okt 2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxidative stress parameters |  | okt 2008 |