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

Gut Health Clinical Trial

Official title:

Effects of Butyrate on Colonic Health of Patients With Diarrhoea Predominant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00696098
• Other study ID #: 06-3-067
• 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
• 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

Related Conditions & MeSH terms

• Diarrhea
• Gut Health

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