ENterogermina® (Bacillus Clausii) In the manaGeMent of diarrheA in 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

PHASE3

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Brief Summary

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Primary:

* To demonstrate the efficacy of Enterogermina® in reducing the duration of acute diarrhea in children

Secondary:

* To evaluate the safety of Enterogermina® in acute diarrhea in Indian children

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Detailed Description

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Conditions

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Gastroenteritis

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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1

Administration of oral rehydration therapy with Bacillus clausii probiotic strain (1 vial twice daily, each vial containing 2 billion spores of Bacillus clausii)

Group Type ACTIVE_COMPARATOR

Bacillus Clausii

Intervention Type DRUG

For 5 days

2

Administration of Oral rehydration therapy

Group Type PLACEBO_COMPARATOR

Oral rehydration therapy

Intervention Type OTHER

For 5 days

Interventions

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Bacillus Clausii

For 5 days

Intervention Type DRUG

Oral rehydration therapy

For 5 days

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Non hospitalised infants and children attending clinic/outpatients with acute diarrhea (\>3 liquid or watery stools occurring in a 24-hour period) of less than 48 hours duration

Exclusion Criteria

* History of presence of blood, pus, or mucus in stools
* Severe dehydration (World Health Organization criteria)
* Severely malnourished patients
* Treatment with antibiotics, probiotics, or prebiotics within a period of 2 weeks before enrolment
* History of conditions known to producing immunodeficiency (Acquired Immune Deficiency Syndrome, other congenital immunodeficiency syndrome, drug therapy with steroids, anticancer drugs etc)
* Known hypersensitivity to Bacillus clausii or other probiotics.

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