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

This study has been completed.
Sponsor:
Collaborator:
Top Institute Food and Nutrition
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00696098
First received: June 9, 2008
Last updated: October 6, 2009
Last verified: October 2009

June 9, 2008
October 6, 2009
May 2007
September 2009   (final data collection date for primary outcome measure)
inflammatory parameters [ Time Frame: okt 2008 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00696098 on ClinicalTrials.gov Archive Site
oxidative stress parameters [ Time Frame: okt 2008 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of Butyrate on Colonic Health of Patients With Diarrhoea Predominant IBS and UC in Remission
Effects of Butyrate on Colonic Health of Patients With Diarrhoea Predominant

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Gut Health
  • Other: sodium butyrate
    1 enema (60 ml) once daily containing 100mM
  • Other: NaCl
    1 enema (60 ml) once daily containing 0.9%NaCl
  • Experimental: 1
    sodium butyrate
    Intervention: Other: sodium butyrate
  • Placebo Comparator: 2
    Intervention: Other: NaCl
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
October 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00696098
06-3-067
No
Fred Troost, University of Maastricht
Maastricht University Medical Center
Top Institute Food and Nutrition
Principal Investigator: Fred Troost, PhD Maastricht University
Maastricht University Medical Center
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP