Back to resultsENterogermina® (Bacillus Clausii) In the manaGeMent of diarrheA in Children (ENIGMA)
Primary Purpose
Gastroenteritis
Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Bacillus Clausii
Oral rehydration therapy
Sponsored by
About this trial
This is an interventional treatment trial for Gastroenteritis
Eligibility 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.
Sites / Locations
- Sanofi-Aventis
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Administration of oral rehydration therapy with Bacillus clausii probiotic strain (1 vial twice daily, each vial containing 2 billion spores of Bacillus clausii)
Administration of Oral rehydration therapy
Outcomes
Primary Outcome Measures
Reduction in duration of diarrhea
Incidence of adverse events
Secondary Outcome Measures
Mean number of stools per day
Effect on consistency of stools
Vomiting episodes per day
Requirement of unscheduled intravenous transfusion
Need for hospitalization
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00457353
Brief Title
ENterogermina® (Bacillus Clausii) In the manaGeMent of diarrheA in Children
Acronym
ENIGMA
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 Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroenteritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
264 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Administration of oral rehydration therapy with Bacillus clausii probiotic strain (1 vial twice daily, each vial containing 2 billion spores of Bacillus clausii)
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Administration of Oral rehydration therapy
Intervention Type
Drug
Intervention Name(s)
Bacillus Clausii
Intervention Description
For 5 days
Intervention Type
Other
Intervention Name(s)
Oral rehydration therapy
Intervention Description
For 5 days
Primary Outcome Measure Information:
Title
Reduction in duration of diarrhea
Time Frame
Throughout the treatment period
Title
Incidence of adverse events
Time Frame
Throughout the study period
Secondary Outcome Measure Information:
Title
Mean number of stools per day
Time Frame
Throughout the treatment period
Title
Effect on consistency of stools
Time Frame
Throughtout the treatment period
Title
Vomiting episodes per day
Time Frame
Throughout the treatment period
Title
Requirement of unscheduled intravenous transfusion
Time Frame
Throughout the study period
Title
Need for hospitalization
Time Frame
Throughout the treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shah Pratik
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Mumbai
Country
India
12. IPD Sharing Statement
Learn more about this trial
ENterogermina® (Bacillus Clausii) In the manaGeMent of diarrheA in Children
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