Impact of Bacillus Clausii Administration on Irritable Bowel Syndrome Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-12

Study Completion Date

2017-11-23

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.

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Detailed Description

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Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bacillus clausii

Bacillus clausii administered orally for two weeks plus standard dietary advice for non-constipated irritable bowel syndrome

Group Type EXPERIMENTAL

Bacillus clausii

Intervention Type DRUG

Oral suspension administered BID

Antispasmodic

Trimebutine administered orally for two weeks plus standard dietary advice for non-constipated irritable bowel syndrome

Group Type OTHER

Trimebutine

Intervention Type DRUG

One tablet of 200 mg of trimebutine administered BID

Interventions

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Bacillus clausii

Oral suspension administered BID

Intervention Type DRUG

Trimebutine

One tablet of 200 mg of trimebutine administered BID

Intervention Type DRUG

Other Intervention Names

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Dietary advice

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No