Skip to main content
OpenTrials
Completed

NCT Number: NCT03359499

Impact of Bacillus Clausii Administration on Irritable Bowel Syndrome Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hospital Britanico

Buenos Aires, Buenos Aires F.D., 1012, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bacillus clausii

Drug

Oral suspension administered BID

Other names: Dietary advice

Trimebutine

Drug

One tablet of 200 mg of trimebutine administered BID

Primary outcomes

  1. Symptomatic response

    Time frame: 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 outcomes

  1. Symptomatic relapse

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospital Britanico

Other

Registry information

Official study title

Impact of Bacillus Clausii Administration on Irritable Bowel Syndrome Patients - a Pilot Study

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 2, 2017
Registry last updated
Mar 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.