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

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ClinicalTrials.gov Identifier: NCT00457353
Recruitment Status : Completed
First Posted : April 6, 2007
Last Update Posted : January 21, 2009
Sponsor:
Information provided by:
Sanofi

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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 or disease Intervention/treatment Phase
Gastroenteritis Drug: Bacillus Clausii Other: Oral rehydration therapy Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : March 2007
Actual Primary Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Reduction in duration of diarrhea [ Time Frame: Throughout the treatment period ]
  2. Incidence of adverse events [ Time Frame: Throughout the study period ]

Secondary Outcome Measures :
  1. Mean number of stools per day [ Time Frame: Throughout the treatment period ]
  2. Effect on consistency of stools [ Time Frame: Throughtout the treatment period ]
  3. Vomiting episodes per day [ Time Frame: Throughout the treatment period ]
  4. Requirement of unscheduled intravenous transfusion [ Time Frame: Throughout the study period ]
  5. Need for hospitalization [ Time Frame: Throughout the treatment period ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00457353


Locations
India
Sanofi-Aventis
Mumbai, India
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Shah Pratik Sanofi
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00457353     History of Changes
Other Study ID Numbers: ENTER_L_01486
First Posted: April 6, 2007    Key Record Dates
Last Update Posted: January 21, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Diarrhea
Gastroenteritis
Signs and Symptoms, Digestive
 Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases