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

January 20, 2009 updated by: Sanofi

Phase III Comparative Study to Assess the Efficacy and Safety of Oral Rehydration Therapy (ORT) in Combination With Spores of Bacillus Clausii (Enterogermina)Versus ORT Alone, Administered for 5 Days With the Treatment of Acute Diarrhea in Children.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

264

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Mumbai, India
        • Sanofi-Aventis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Administration of oral rehydration therapy with Bacillus clausii probiotic strain (1 vial twice daily, each vial containing 2 billion spores of Bacillus clausii)
Drug: Bacillus Clausii
For 5 days
Placebo Comparator: 2
Administration of Oral rehydration therapy
Other: Oral rehydration therapy
For 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in duration of diarrhea
Time Frame: Throughout the treatment period
Throughout the treatment period
Incidence of adverse events
Time Frame: Throughout the study period
Throughout the study period

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean number of stools per day
Time Frame: Throughout the treatment period
Throughout the treatment period
Effect on consistency of stools
Time Frame: Throughtout the treatment period
Throughtout the treatment period
Vomiting episodes per day
Time Frame: Throughout the treatment period
Throughout the treatment period
Requirement of unscheduled intravenous transfusion
Time Frame: Throughout the study period
Throughout the study period
Need for hospitalization
Time Frame: Throughout the treatment period
Throughout the treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Shah Pratik, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

April 5, 2007

First Submitted That Met QC Criteria

April 5, 2007

First Posted (Estimate)

April 6, 2007

Study Record Updates

Last Update Posted (Estimate)

January 21, 2009

Last Update Submitted That Met QC Criteria

January 20, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENTER_L_01486

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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