Impact of Bacillus Clausii Administration on Irritable Bowel Syndrome Patients

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03359499
• Other study ID #: HB744
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 25, 2017
• Last updated: March 11, 2018
• Start date: August 12, 2017
• Est. completion date: November 23, 2017

Study information

• Verified date: March 2018
• Source: Hospital Britanico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 23, 2017
• Est. primary completion date: October 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Bacillus clausii
Oral suspension administered BID
• Trimebutine
One tablet of 200 mg of trimebutine administered BID

Locations

Country	Name	City	State
Argentina	Hospital Britanico	Buenos Aires	Caba

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Britanico

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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