Evaluation Of Bacillus Clausii In Treatment Of Acute Diarrhea In Latin American Children

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

PHASE4

Total Enrollment

629 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-01-31

Brief Summary

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Primary Objective:

To demonstrate the effectiveness of treatment with Bacillus clausii probiotic strain (Enterogermina) in combination with oral rehydration therapy (ORT) for a period of 5 days, in the duration of acute community-acquired diarrhea in Latin American children.

Secondary Objectives:

To evaluate the clinical safety of Enterogermina in acute diarrhea in children and to demonstrate its effectiveness on stool frequency, stool consistency, and number of vomiting episodes.

To evaluate parent's overall global assessment. To evaluate the safety and effectiveness of Enterogermina in norovirus acute gastroenteritis (AGE).

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Detailed Description

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The maximum duration of study participation for each patient can be 10 days.

Conditions

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Acute Gastroenteritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Enterogermina + Enterolyte

2 vials of Enterogermina per day for 5 days and Enterolyte according to investigator´s recommendation

Group Type EXPERIMENTAL

Bacillus clausii

Intervention Type DRUG

Pharmaceutical form:aqueous suspension Route of administration: oral

Oral Rehydration Therapy

Intervention Type DRUG

Pharmaceutical form:vials/sachets for solution Route of administration: oral

Interventions

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Bacillus clausii

Pharmaceutical form:aqueous suspension Route of administration: oral

Intervention Type DRUG

Oral Rehydration Therapy

Pharmaceutical form:vials/sachets for solution Route of administration: oral

Intervention Type DRUG

Other Intervention Names

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Enterogermina Enterolyte

Eligibility Criteria

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Inclusion Criteria

Infants or children with acute community-acquired diarrhea (≥3 liquid or watery stools occurring in a 24-hour period):

* with less than 48 hours duration
* aged between 6 months and 5 years of age
* whose parents or legal guardians have given their written informed consent
* with clinical indication for ORT per formula of World Health Organization

Exclusion Criteria

Infants or children with:

* presence of blood, pus, or mucus in stools
* severe dehydration
* untreatable vomiting
* antibiotics indication for the treatment of this acute diarrhea;
* hospitalization
* expected hospitalization for the next hours due to the poor clinical conditions
* treatment with antibiotics, probiotics, or prebiotics within a period of 2 weeks before enrolment (the use of probiotics and prebiotics in dairy food such as yoghurt, cheese, milk prior to the study is permitted)
* previous use (within 48 hours) of kaolin, pectin, bismuth subsalicylate, racecadotril, loperamide, atropine and other anticholinergic agents
* indication of any other ORT different from the one prescribed in the study
* chronic diseases including chronic diarrhea
* immunodeficiency (acquired or congenital immunodeficiency)
* other infectious comorbid conditions
* known hypersensitivity to Bacillus clausii (Enterogermina) or other probiotics
* parent/legal guardian who, in the opinion of the Investigator, is unable to complete the patient diary or bring the child for the follow-up visit
* participation in another clinical trial in the last 3 months prior to the start of the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Minimum Eligible Age

6 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No