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ENterogermina® (Bacillus Clausii) In the manaGeMent of diarrheA in Children (ENIGMA)
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00457353
First received: April 5, 2007
Last updated: January 20, 2009
Last verified: January 2009
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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 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. |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Reduction in duration of diarrhea [ Time Frame: Throughout the treatment period ]
- Incidence of adverse events [ Time Frame: Throughout the study period ]
Secondary Outcome Measures:
- 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 ]
| 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) |
| 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00457353
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 |
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 21, 2017