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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).
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
Not yet recruiting
The Baruch Padeh Medical Center, Poriya
Published on BioPortfolio: 2014-07-24T14:07:19-0400
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Crohn's disease (CD) is an autoimmune disorder which affects over 700,000 people in the U.S. The disease can vary in severity and multiple drug classes are available to the disease depend...
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A chronic transmural inflammation that may involve any part of the DIGESTIVE TRACT from MOUTH to ANUS, mostly found in the ILEUM, the CECUM, and the COLON. In Crohn disease, the inflammation, extending through the intestinal wall from the MUCOSA to the serosa, is characteristically asymmetric and segmental. Epithelioid GRANULOMAS may be seen in some patients.
A condition characterized by persistent or recurrent labial enlargement, ORAL ULCER, and other orofacial manifestations in the absence of identifiable CROHN DISEASE; or SARCOIDOSIS. There is no consensus on whether orofacial granulomatosis is a distinct clinical disorder or an initial presentation of Crohn disease.
Live microbial DIETARY SUPPLEMENTS which beneficially affect the host animal by improving its intestinal microbial balance. Antibiotics and other related compounds are not included in this definition. In humans, lactobacilli are commonly used as probiotics, either as single species or in mixed culture with other bacteria. Other genera that have been used are bifidobacteria and streptococci. (J. Nutr. 1995;125:1401-12)
Chronic, non-specific inflammation of the GASTROINTESTINAL TRACT. Etiology may be genetic or environmental. This term includes CROHN DISEASE and ULCERATIVE COLITIS.
A chimeric monoclonal antibody to TNF ALPHA that is used in the treatment of RHEUMATOID ARTHRITIS; ANKYLOSING SPONDYLITIS; PSORIATIC ARTHRITIS and CROHN'S DISEASE.
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Crohn's Disease (CD)
Crohn’s disease (CD) is a long-term condition that causes inflammation of the lining of the digestive system. Inflammation can affect any part of the digestive system, from the mouth to the back passage, but most commonly occurs in the last s...