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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:

MedlinePlus related topics: Diarrhea
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   (Child)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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:
Diarrhea
Gastroenteritis
Signs and Symptoms, Digestive
 Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 29, 2016