Gut Health Clinical Trial
Official title:
Effects of Butyrate on Colonic Health of Patients With Diarrhoea Predominant
Verified date | October 2009 |
Source | Maastricht University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | October 2009 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | University of Maastricht | Maastricht | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center | Top Institute Food and Nutrition |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | inflammatory parameters | okt 2008 | ||
Secondary | oxidative stress parameters | okt 2008 |
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