Effects of Butyrate on Colonic Health of Patients With Diarrhoea Predominant IBS and UC in Remission
Primary Purpose
Gut Health
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
sodium butyrate
NaCl
Sponsored by
About this trial
This is an interventional basic science trial for Gut Health
Eligibility Criteria
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
Sites / Locations
- University of Maastricht
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
sodium butyrate
Outcomes
Primary Outcome Measures
inflammatory parameters
Secondary Outcome Measures
oxidative stress parameters
Full Information
NCT ID
NCT00696098
First Posted
June 9, 2008
Last Updated
February 22, 2017
Sponsor
Maastricht University Medical Center
Collaborators
Top Institute Food and Nutrition
1. Study Identification
Unique Protocol Identification Number
NCT00696098
Brief Title
Effects of Butyrate on Colonic Health of Patients With Diarrhoea Predominant IBS and UC in Remission
Official Title
Effects of Butyrate on Colonic Health of Patients With Diarrhoea Predominant
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Top Institute Food and Nutrition
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gut Health
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
sodium butyrate
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
sodium butyrate
Intervention Description
1 enema (60 ml) once daily containing 100mM
Intervention Type
Other
Intervention Name(s)
NaCl
Intervention Description
1 enema (60 ml) once daily containing 0.9%NaCl
Primary Outcome Measure Information:
Title
inflammatory parameters
Time Frame
okt 2008
Secondary Outcome Measure Information:
Title
oxidative stress parameters
Time Frame
okt 2008
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fred Troost, PhD
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maastricht
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6202 MD
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Effects of Butyrate on Colonic Health of Patients With Diarrhoea Predominant IBS and UC in Remission
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