NCT03359499

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 12, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2017

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 2, 2017

Completed
Last Updated

March 13, 2018

Status Verified

March 1, 2018

Enrollment Period

2 months

First QC Date

November 25, 2017

Last Update Submit

March 11, 2018

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Symptomatic relapse

    Four weeks after treatment completion

Study Arms (2)

Bacillus clausii

EXPERIMENTAL

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

Drug: Bacillus clausii

Antispasmodic

OTHER

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

Drug: Trimebutine

Interventions

Bacillus clausiiDRUG

Oral suspension administered BID

Also known as: Dietary advice
Bacillus clausii
TrimebutineDRUG

One tablet of 200 mg of trimebutine administered BID

Antispasmodic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients with non-constipated irritable bowel syndrome according to Rome IV criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Britanico

Buenos Aires, Buenos Aires F.D., 1012, Argentina

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

clausin peptide, Bacillus clausiiNutrition AssessmentTrimebutine

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthHydroxybenzoate EthersHydroxybenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenyl EthersPhenols

Study Officials

  • Juan S Lasa, MD

    Hospital Britanico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 25, 2017

First Posted

December 2, 2017

Study Start

August 12, 2017

Primary Completion

October 25, 2017

Study Completion

November 23, 2017

Last Updated

March 13, 2018

Record last verified: 2018-03

Locations

AR(1)