Impact of Bacillus Clausii Administration on Irritable Bowel Syndrome Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: Bacillus clausii
* Drug: Trimebutine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |