Effects of Butyrate on Colonic Health of Patients With Diarrhoea Predominant IBS and UC in Remission
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|ClinicalTrials.gov Identifier: NCT00696098|
Recruitment Status : Completed
First Posted : June 12, 2008
Last Update Posted : February 24, 2017
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 or disease||Intervention/treatment||Phase|
|Gut Health||Other: sodium butyrate Other: NaCl||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Effects of Butyrate on Colonic Health of Patients With Diarrhoea Predominant|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||October 2009|
Other: sodium butyrate
1 enema (60 ml) once daily containing 100mM
|Placebo Comparator: 2||
1 enema (60 ml) once daily containing 0.9%NaCl
- inflammatory parameters [ Time Frame: okt 2008 ]
- oxidative stress parameters [ Time Frame: okt 2008 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00696098
|University of Maastricht|
|Maastricht, Limburg, Netherlands, 6202 MD|
|Principal Investigator:||Fred Troost, PhD||Maastricht University|