Probiotics for the Treatment of Irritable Bowel Syndrome in Celiac Patients (ProCel)
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ClinicalTrials.gov Identifier: NCT01699191
Recruitment Status : Unknown
Verified October 2012 by Ruggiero Francavilla, University of Bari. Recruitment status was: Not yet recruiting
Probiotics play an important role in preventing overgrowth of potentially pathogenic bacteria and maintaining the integrity of the gut mucosal barrier. The beneficial effects of probiotics have been previously studied in adult patients with IBS. Clinical studies show that patients meeting the criteria for diagnosis for IBS have greater probability for being affected by celiac desease if compared to controls without IBS. Since one of the causes attributed to the onset of IBS is the modified flora gut, it is interesting to determine the beneficial effects that probiotics may have on gastrointestinal symptoms in celiac disease patients. The goal of the present study is to determine whether oral administration of a probiotic mixture of Lactobacillus plantarum 14D-CECT 4528, Lactobacillus casei, Bifidobacterium breve Bbr8 LMG P-17501, Bifidobacterium breve Bl10 LMG P-17500 and Bifidobacterium animalis under randomized, double-blind, placebo-controlled conditions would improve symptoms of adult celiac patients with IBS.
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Ages Eligible for Study:
18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Celiac patients aged between 18 and 65 years
Diagnosis of IBS on the basis of Rome III criteria
Previous sigmoidoscopy or colonoscopy in the past 5 years
Known concomitant organic diseases, including inflammatory bowel disease and other systemic diseases significant
Treatment with antispasmodic drugs within the previous month
Previous abdominal surgery, with the exception of the hernia repair or appendectomy
Treatment with antibiotics within the previous month
Treatment with probiotics and / or prebiotics within the previous month