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Impact of Bacillus Clausii Administration on Irritable Bowel Syndrome Patients

NCT03359499 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-03-13

No results posted yet for this study

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.

Conditions

  • Irritable Bowel Syndrome

Interventions

DRUG

Bacillus clausii

Oral suspension administered BID

DRUG

Trimebutine

One tablet of 200 mg of trimebutine administered BID

Sponsors & Collaborators

  • Hospital Britanico

    lead OTHER

Principal Investigators

  • Juan S Lasa, MD · Hospital Britanico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Argentina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03359499 on ClinicalTrials.gov