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

Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT00457353
Collaborator
(none)
264
Enrollment
1
Location
2
Arms

Study Details

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
Condition or Disease Intervention/Treatment Phase
  • Drug: Bacillus Clausii
  • Other: Oral rehydration therapy
 Phase 3

Study Design

Study Type:
Interventional
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 :
Mar 1, 2007
Actual Primary Completion Date :
Dec 1, 2007

Arms and Interventions

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

Primary Outcome Measures

  1. Reduction in duration of diarrhea [Throughout the treatment period]

  2. Incidence of adverse events [Throughout the study period]

Secondary Outcome Measures

  1. Mean number of stools per day [Throughout the treatment period]

  2. Effect on consistency of stools [Throughtout the treatment period]

  3. Vomiting episodes per day [Throughout the treatment period]

  4. Requirement of unscheduled intravenous transfusion [Throughout the study period]

  5. Need for hospitalization [Throughout the treatment period]

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Months to 5 Years
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sanofi-Aventis Mumbai India

Sponsors and Collaborators

  • Sanofi

Investigators

  • Study Director: Shah Pratik, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00457353
Other Study ID Numbers:
  • ENTER_L_01486
First Posted:
Apr 6, 2007
Last Update Posted:
Jan 21, 2009
Last Verified:
Jan 1, 2009
Additional relevant MeSH terms:
Gastroenteritis
Diarrhea

Study Results

No Results Posted as of Jan 21, 2009