The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation, Endothelial Function, and Markers of Inflammation
Primary Purpose
Crohn's Disease, Ulcerative Colitis
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
probiotics
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Crohn's Disease focused on measuring Crohn's disease activity index, CDAI
Eligibility Criteria
Inclusion Criteria:
- patients with ulcerative colitis and crohns' disease
Exclusion Criteria:.
- notable caveats are that arteries smaller than 2.5 mm
Sites / Locations
Outcomes
Primary Outcome Measures
Truelove and Witts Classification of Ulcerative Colitis
Crohn's disease activity index (CDAI)
Secondary Outcome Measures
Full Information
NCT ID
NCT01078935
First Posted
March 1, 2010
Last Updated
August 10, 2011
Sponsor
The Baruch Padeh Medical Center, Poriya
Collaborators
Ministry of Health, Israel
1. Study Identification
Unique Protocol Identification Number
NCT01078935
Brief Title
The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation, Endothelial Function, and Markers of Inflammation
Official Title
The Effect of Probiotics on Bowel Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
The Baruch Padeh Medical Center, Poriya
Collaborators
Ministry of Health, Israel
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Fifty patients will get probiotics (109 bacteria [L. acidophilus, B. bifidum, S. thermophilus, L. rhamnosus, L. casei] in 2 capsules) and half will get placebo (2 capsules that look the same like the probiotic capsules and will contain microcrystalline cellulose, artificial brown color, magnesium strearate, and silica dioxide). The patients and the staff will be blinded to the identity of the study medications.
Each patient and volunteer will get the study medication for 6 weeks and will be evaluated twice - before enrollment and after 6 weeks of treatment. Routine clinical management will continue - with regular treatment as needed.
Each individual will be studied for changes in biochemical inflammatory and immunological markers and changes in flow medicated diameter that will be measured by the brachial artery method (that is evaluating endothelial function). Every patient will be evaluated for his/her ability to produce endothelial progenitor stem cells (EPCs).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease, Ulcerative Colitis
Keywords
Crohn's disease activity index, CDAI
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Dietary Supplement
Intervention Name(s)
probiotics
Intervention Description
Each patient and volunteer will get the study medication for 6 weeks and will be evaluated twice - before enrollment and after 6 weeks of treatment. Routine clinical management will continue - with regular treatment as needed.
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
Each patient and volunteer will get the study medication for 6 weeks and will be evaluated twice - before enrollment and after 6 weeks of treatment. Routine clinical management will continue - with regular treatment as needed.
Primary Outcome Measure Information:
Title
Truelove and Witts Classification of Ulcerative Colitis
Time Frame
2 years
Title
Crohn's disease activity index (CDAI)
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with ulcerative colitis and crohns' disease
Exclusion Criteria:.
notable caveats are that arteries smaller than 2.5 mm
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arnon Blum, DR
Phone
972466522688
Email
ablum@poria.health.gov.il
12. IPD Sharing Statement
Learn more about this trial
The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation, Endothelial Function, and Markers of Inflammation
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