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Impact of Bacillus Clausii Administration on Irritable Bowel Syndrome Patients

Primary Purpose

Irritable Bowel Syndrome

Status

Completed

Phase

Phase 2

Locations

Argentina

Study Type

Interventional

Intervention

Bacillus clausii

Trimebutine

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital Britanico

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Bacillus clausii

Antispasmodic

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03359499

First Posted

November 25, 2017

Last Updated

March 11, 2018

Sponsor

Hospital Britanico

1. Study Identification

Unique Protocol Identification Number

NCT03359499

Brief Title

Impact of Bacillus Clausii Administration on Irritable Bowel Syndrome Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

August 12, 2017 (Actual)

Primary Completion Date

October 25, 2017 (Actual)

Study Completion Date

November 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Britanico

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bacillus clausii

Arm Type

Experimental

Arm Description

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

Arm Title

Antispasmodic

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Bacillus clausii

Other Intervention Name(s)

Dietary advice

Intervention Description

Oral suspension administered BID

Intervention Type

Drug

Intervention Name(s)

Trimebutine

Intervention Description

One tablet of 200 mg of trimebutine administered BID

Primary Outcome Measure Information:

Title

Symptomatic response

Description

Time Frame

After two weeks of treatment

Secondary Outcome Measure Information:

Title

Symptomatic relapse

Description

Time Frame

Four weeks after treatment completion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Juan S Lasa, MD

Organizational Affiliation

Hospital Britanico

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Britanico

City

Buenos Aires

State/Province

Caba

ZIP/Postal Code

1012

Country

Argentina

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Impact of Bacillus Clausii Administration on Irritable Bowel Syndrome Patients

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