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

Gastroenteritis Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00457353
• Other study ID #: ENTER_L_01486
• Status: Completed
• Phase: Phase 3
• First received: April 5, 2007
• Last updated: January 20, 2009
• Start date: March 2007

Study information

• Verified date: January 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 5 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroenteritis

Intervention

Drug:
• Bacillus Clausii
For 5 days

Other:
• Oral rehydration therapy
For 5 days

Locations

Country	Name	City	State
India	Sanofi-Aventis	Mumbai

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in duration of diarrhea		Throughout the treatment period	No
Primary	Incidence of adverse events		Throughout the study period	Yes
Secondary	Mean number of stools per day		Throughout the treatment period	No
Secondary	Effect on consistency of stools		Throughtout the treatment period	No
Secondary	Vomiting episodes per day		Throughout the treatment period	No
Secondary	Requirement of unscheduled intravenous transfusion		Throughout the study period	No
Secondary	Need for hospitalization		Throughout the treatment period	No