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

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Gut Health

Treatments: Other: sodium butyrate; Other: NaCl

Study type: Interventional

Funder types: Other

Identifiers

NCT00696098

06-3-067

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

80 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

sodium butyrate

Treatment:

Other: sodium butyrate

2

Placebo Comparator group

Treatment:

Other: NaCl