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
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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 |
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Gastroenteritis | Drug: Bacillus Clausii Other: Oral rehydration therapy | Phase 3 |
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 |
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)
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Drug: Bacillus Clausii
For 5 days |
Placebo Comparator: 2
Administration of Oral rehydration therapy
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Other: Oral rehydration therapy
For 5 days |
- Reduction in duration of diarrhea [ Time Frame: Throughout the treatment period ]
- Incidence of adverse events [ Time Frame: Throughout the study period ]
- 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 ]

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Ages Eligible for Study: | 6 Months to 5 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
India | |
Sanofi-Aventis | |
Mumbai, India |
Study Director: | Shah Pratik | Sanofi |
Responsible Party: | Medical Affairs Study Director, sanofi-aventis |
ClinicalTrials.gov Identifier: | NCT00457353 |
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 |
Gastroenteritis Diarrhea Signs and Symptoms, Digestive Gastrointestinal Diseases Digestive System Diseases |