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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00696098
Other study ID # 06-3-067
Secondary ID
Status Completed
Phase N/A
First received June 9, 2008
Last updated February 22, 2017
Start date May 2007
Est. completion date October 2009

Study information

Verified date October 2009
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
sodium butyrate
1 enema (60 ml) once daily containing 100mM
NaCl
1 enema (60 ml) once daily containing 0.9%NaCl

Locations

Country Name City State
Netherlands University of Maastricht Maastricht Limburg

Sponsors (2)

Lead Sponsor Collaborator
Maastricht University Medical Center Top Institute Food and Nutrition

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary inflammatory parameters okt 2008
Secondary oxidative stress parameters okt 2008
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