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

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00457353

First received: April 5, 2007

Last updated: January 20, 2009

Last verified: January 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

April 5, 2007

Last Updated Date

January 20, 2009

Start Date ^ICMJE

March 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Reduction in duration of diarrhea [ Time Frame: Throughout the treatment period ] [ Designated as safety issue: No ]
Incidence of adverse events [ Time Frame: Throughout the study period ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Reduction in duration of diarrhea
Incidence of adverse events

Change History

Complete list of historical versions of study NCT00457353 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Mean number of stools per day [ Time Frame: Throughout the treatment period ] [ Designated as safety issue: No ]
Effect on consistency of stools [ Time Frame: Throughtout the treatment period ] [ Designated as safety issue: No ]
Vomiting episodes per day [ Time Frame: Throughout the treatment period ] [ Designated as safety issue: No ]
Requirement of unscheduled intravenous transfusion [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]
Need for hospitalization [ Time Frame: Throughout the treatment period ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Mean number of stools per day
Effect on consistency of stools
Vomiting episodes per day
Requirement of unscheduled intravenous transfusion
Need for hospitalization

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Gastroenteritis

Intervention ^ICMJE

Drug: Bacillus Clausii
For 5 days
Other: Oral rehydration therapy
For 5 days

Study Arm (s)

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)

Intervention: Drug: Bacillus Clausii
Placebo Comparator: 2
Administration of Oral rehydration therapy

Intervention: Other: Oral rehydration therapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

264

Completion Date

Not Provided

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

6 Months to 5 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

India

Administrative Information

NCT Number ^ICMJE

NCT00457353

Other Study ID Numbers ^ICMJE

ENTER_L_01486

Has Data Monitoring Committee

Responsible Party

Medical Affairs Study Director, sanofi-aventis

Study Sponsor ^ICMJE

Sanofi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Shah Pratik

Sanofi

Information Provided By

Sanofi

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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