Impact of Bacillus Clausii Administration on Irritable Bowel Syndrome Patients

Phase 2

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: Bacillus clausii; Drug: Trimebutine

• Registration Number: NCT03359499
• Lead Sponsor: Hospital Britanico

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-12
• Primary Completion: 2017-10-25
• Study Completion: 2017-11-23
• Study First Submitted: 2017-11-25
• Study First Submitted QC: 2017-11-30
• Study First Posted: 2017-12-02
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-11
• Last Update Posted: 2018-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Adult patients with non-constipated irritable bowel syndrome according to Rome IV criteria

Exclusion Criteria

• Allergy to Bacillus clausii spores
• Prior treatment with antibiotics or probiotics (4 weeks)
• Not willing to fulfill symptom diary
• Pregnancy or breastfeeding
• Clinical suspicion of organic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bacillus clausii	Bacillus clausii	Bacillus clausii administered orally for two weeks plus standard dietary advice for non-constipated irritable bowel syndrome
Antispasmodic	Trimebutine	Trimebutine administered orally for two weeks plus standard dietary advice for non-constipated irritable bowel syndrome

Primary Outcome Measures

Name	Time	Method
Symptomatic response	After two weeks of treatment	Decrease of at least 50% of symptom severity score - The Irritable Bowel Syndrome Symptom Severity Scale, which consists of five visual analogue scale- questions: their values range from 0 to 100, thus the total score ranges from 0 to 500. Based on previously published studies, clinical response will be defined as a decrease in at least 50% of the initial score

Secondary Outcome Measures

Name	Time	Method
Symptomatic relapse	Four weeks after treatment completion	An increase of at least 30% in the symptomatic score based on daily follow up. The score that will be used is the The Irritable Bowel Syndrome Symptom Severity Scale, which consists of five visual analogue scale- questions: their values range from 0 to 100, thus the total score ranges from 0 to 500.

Trial Locations

Locations (1)

Hospital Britanico; 🇦🇷 Buenos Aires, Caba, Argentina