NCT01078935

The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation, Endothelial Function, and Markers of Inflammation

The Effect of Probiotics on Bowel Disease

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: The Baruch Padeh Medical Center, Poriya · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Crohn's Disease
• Ulcerative Colitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	probiotics	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.
DIETARY_SUPPLEMENT	placebo	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.

Timeline

• Start date: 2012-12-01
• Primary completion: 2014-04-01
• First posted: 2010-03-02
• Last updated: 2011-08-11