The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation, Endothelial Function, and Markers of Inflammation
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|ClinicalTrials.gov Identifier: NCT01078935|
Recruitment Status : Unknown
Verified March 2010 by The Baruch Padeh Medical Center, Poriya.
Recruitment status was: Not yet recruiting
First Posted : March 2, 2010
Last Update Posted : August 11, 2011
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).
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease Ulcerative Colitis||Dietary Supplement: probiotics Dietary Supplement: placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||The Effect of Probiotics on Bowel Disease|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||April 2014|
Dietary Supplement: probiotics
- Truelove and Witts Classification of Ulcerative Colitis [ Time Frame: 2 years ]
- Crohn's disease activity index (CDAI) [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01078935
|Contact: Arnon Blum, DRfirstname.lastname@example.org|