ENterogermina® (Bacillus Clausii) In the manaGeMent of di... | NCT00457353

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

NCT00457353

Sponsor

Sanofi

Status

Completed

Last Update Posted

Jan 21, 2009Estimated

Enrollment

264Actual

Phase

Phase 3

Conditions

Gastroenteritis

Interventions

Bacillus Clausii
Oral rehydration therapy

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Dec 2007Actual

Completion Date

Not provided

First Submitted Date

Apr 5, 2007

First Submission Date that Met QC Criteria

Apr 5, 2007

First Posted Date

Apr 6, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2009

Last Update Posted Date

Jan 21, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

264Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	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
2	Placebo Comparator	Administration of Oral rehydration therapy	Other: Oral rehydration therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bacillus Clausii	Drug	For 5 days	1
Oral rehydration therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction in duration of diarrhea		Throughout the treatment period
Incidence of adverse events		Throughout the study period

Secondary Outcomes

Measure	Description	Time Frame
Mean number of stools per day		Throughout the treatment period
Effect on consistency of stools		Throughtout the treatment period
Vomiting episodes per day

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

5 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Shah Pratik	Sanofi	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D005759	Gastroenteritis

Ancestor Terms

ID	Term
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C545326	clausin peptide, Bacillus clausii
D005440	Fluid Therapy

Ancestor Terms

ID	Term
D004358	Drug Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided