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Impact of Bacillus Clausii Administration on Irritable Bowel Syndrome Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03359499
Recruitment Status : Completed
First Posted : December 2, 2017
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Juan Sebastian Lasa, Hospital Britanico

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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: Bacillus clausii Drug: Trimebutine Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Bacillus Clausii Administration on Irritable Bowel Syndrome Patients - a Pilot Study
Actual Study Start Date : August 12, 2017
Actual Primary Completion Date : October 25, 2017
Actual Study Completion Date : November 23, 2017

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 Name: Dietary advice

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




Primary Outcome Measures :
  1. Symptomatic response [ Time Frame: After two weeks of treatment ]
    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 :
  1. Symptomatic relapse [ Time Frame: Four weeks after treatment completion ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03359499


Locations
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Argentina
Hospital Britanico
Buenos Aires, Caba, Argentina, 1012
Sponsors and Collaborators
Hospital Britanico
Investigators
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Principal Investigator: Juan S Lasa, MD Hospital Britanico
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Responsible Party: Juan Sebastian Lasa, Clinical Professor, Hospital Britanico
ClinicalTrials.gov Identifier: NCT03359499    
Other Study ID Numbers: HB744
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Trimebutine
Gastrointestinal Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs