The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation, Endothelial Function, and Markers of Inflammation
Recruitment status was: Not yet recruiting
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).
|Crohn's Disease Ulcerative Colitis||Dietary Supplement: probiotics Dietary Supplement: placebo||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||The Effect of Probiotics on Bowel Disease|
- Truelove and Witts Classification of Ulcerative Colitis [ Time Frame: 2 years ]
- Crohn's disease activity index (CDAI) [ Time Frame: 2 years ]
|Study Start Date:||December 2012|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Dietary Supplement: probiotics
Please refer to this study by its ClinicalTrials.gov identifier: NCT01078935
|Contact: Arnon Blum, DRemail@example.com|