drugset / Trial / NCT03359499

Impact of Bacillus Clausii Administration on Irritable Bowel Syndrome Patients

NCT03359499

Phase 2/3 Completed 80 enrolled Hospital Britanico
RandomizedParallel-groupOpen-labelTreatment

Summary

Probiotics have been proposed as useful therapeutic alternatives for the treatment of irritable bowel syndrome patients. Bacillus clausii is a probiotic that has been used for the treatment of acute diarrhea among adults and pediatric patients, as well as an adjunctive therapy for the treatment for Helicobacter pylori infection. It has been proposed that Bacillus clausii is effective for the treatment of irritable bowel syndrome-related symptoms (especially diarrhea and bloating) in non-controlled trials. The aim of the proposed investigation is to determine whether the administration of Bacillus clausii during two weeks plus dietary advice compared to antispasmodics plus dietary advice would be an effective and safe alternative.

Timeline

Start
2017-08-12
Primary completion
2017-10-25
Completion
2017-11-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Bacillus clausii Other / unclassified Oral
Subject Trimebutine Small molecule 200 mg Oral