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

Sanofi264 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

264

Conditions

Gastroenteritis

Interventions

Bacillus ClausiiDRUG

For 5 days

Oral rehydration therapyOTHER

For 5 days

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 5 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sanofi-Aventis

Mumbai, India

Outcomes

Primary Outcomes

Reduction in duration of diarrhea

Time frame: Throughout the treatment period

Incidence of adverse events

Time frame: Throughout the study period

Secondary Outcomes

Mean number of stools per day

Time frame: Throughout the treatment period

Effect on consistency of stools

Time frame: Throughtout the treatment period

Vomiting episodes per day

Time frame: Throughout the treatment period

Requirement of unscheduled intravenous transfusion

Time frame: Throughout the study period

Need for hospitalization

Time frame: Throughout the treatment period

Data from ClinicalTrials.gov

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