Gut Health
Conditions
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.
Interventions
OTHERsodium butyrate
1 enema (60 ml) once daily containing 100mM
OTHERNaCl
1 enema (60 ml) once daily containing 0.9%NaCl
Sponsors
Top Institute Food and Nutrition
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| inflammatory parameters | okt 2008 |
Secondary
| Measure | Time frame |
|---|---|
| oxidative stress parameters | okt 2008 |
Countries
Netherlands
Outcome results
None listed