Clinical Research Directory

The Efficacy of Lactobacillous Probiotic and Trace Elements in the Management of Ulcerative Colitis Patients the Patient Will be Recruited From Outpatient Clinic of IBD and Gastroenterology of the National Hepatology and Tropical Medicine Research Institute (NHTMRI), Cairo, Egypt.

Sponsor: National Hepatology & Tropical Medicine Research Institute

Summary

the goal of this interventional observational study is to To evaluate the efficacy , safety of lactobacillus probiotics or trace elements when added to UC standard of care in maintaining remission in UC patients and to To compare the efficacy of adding lactobacillus probiotics versus adding trace elements to UC standard of care This study will be open label, parallel, prospective interventional study which will be conducted in the outpatient clinic of IBD and gastroenterology of the National Hepatology and tropical medicine research institute (NHTMRI), Cairo, Egypt. The recruited patients will be randomly allocated in one of three groups: Group I. Study group 1 Forty-four patients will receive 20 billion colony forming unit (CFU) of Lactobacillus acidophilus for six months together with IBD standard of care (biological therapy e.g., infliximab in a dose of 5mg/kg ) Group II. Study group 2 Forty-four patients will receive 1 tablet twice daily of trace elements (zinc 15 mg, chromium 15 mcg, selenium 15 mcg, copper 1000 mcg, iodine 75 mcg, iron 30 mg, magnesium 2.5 mg, molybdenum 15 mcg) as Vitayami® together with the IBD standard of care biological therapy e.g., infliximab in a dose of 5mg/kg) Group III. Control group Forty-four Patients will be receiving the UC standard of care (biological therapy e.g., infliximab in a dose of 5mg/kg) according to the hospital protocol without receiving lactobacillus or trace elements. Primary outcome The decline in the inflammatory bowel disease activity index to less than 50% compared to baseline. Secondary outcome The improvement in mucosal healing measured by colonoscopy compared to baseline.

Official title: The Efficacy of Lactobacillous Probiotic and Trace Elements in the Management of Ulcerative Colitis Patients

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