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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00457353
First received: April 5, 2007
Last updated: January 20, 2009
Last verified: January 2009
History of Changes
  Purpose

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

Condition Intervention Phase
Gastroenteritis
 Drug: Bacillus Clausii
Other: Oral rehydration therapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Reduction in duration of diarrhea [ Time Frame: Throughout the treatment period ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: Throughout the study period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mean number of stools per day [ Time Frame: Throughout the treatment period ] [ Designated as safety issue: No ]
  • Effect on consistency of stools [ Time Frame: Throughtout the treatment period ] [ Designated as safety issue: No ]
  • Vomiting episodes per day [ Time Frame: Throughout the treatment period ] [ Designated as safety issue: No ]
  • Requirement of unscheduled intravenous transfusion [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]
  • Need for hospitalization [ Time Frame: Throughout the treatment period ] [ Designated as safety issue: No ]

Enrollment: 264
Study Start Date: March 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00457353

Locations
India
Sanofi-Aventis
Mumbai, India
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Shah Pratik Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00457353     History of Changes
Other Study ID Numbers: ENTER_L_01486
Study First Received: April 5, 2007
Last Updated: January 20, 2009
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 22, 2013