Impact of Bacillus Clausii Administration on Irritable Bowel Syndrome Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Drug: Bacillus clausii; Drug: Trimebutine

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Caba
    • Buenos Aires, Caba, Argentina, 1012
      • Hospital Británico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bacillus clausii; Bacillus clausii administered orally for two weeks plus standard dietary advice for non-constipated irritable bowel syndrome	Drug: Bacillus clausii; Oral suspension administered BID; Other Names: Dietary advice
Other: Antispasmodic; Trimebutine administered orally for two weeks plus standard dietary advice for non-constipated irritable bowel syndrome	Drug: Trimebutine; One tablet of 200 mg of trimebutine administered BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptomatic response	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	After two weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptomatic relapse	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.	Four weeks after treatment completion

Collaborators and Investigators

• Sponsor: Hospital Britanico
• Investigators: Principal Investigator: Juan S Lasa, MD, Hospital Británico

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2017
• Primary Completion (Actual): October 25, 2017
• Study Completion (Actual): November 23, 2017

Study Registration Dates

• First Submitted: November 25, 2017
• First Submitted That Met QC Criteria: November 30, 2017
• First Posted (Actual): December 2, 2017

Study Record Updates

• Last Update Posted (Actual): March 13, 2018
• Last Update Submitted That Met QC Criteria: March 11, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Physiological Effects of Drugs; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Trimebutine
• Other Study ID Numbers: HB744

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No