NCT00457353

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 6, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Last Updated

January 21, 2009

Status Verified

January 1, 2009

Enrollment Period

9 months

First QC Date

April 5, 2007

Last Update Submit

January 20, 2009

Conditions

Gastroenteritis

Outcome Measures

Primary Outcomes (2)

  • Reduction in duration of diarrhea

    Throughout the treatment period

  • Incidence of adverse events

    Throughout the study period

Secondary Outcomes (5)

  • Mean number of stools per day

    Throughout the treatment period

  • Effect on consistency of stools

    Throughtout the treatment period

  • Vomiting episodes per day

    Throughout the treatment period

  • Requirement of unscheduled intravenous transfusion

    Throughout the study period

  • Need for hospitalization

    Throughout the treatment period

Study Arms (2)

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

Bacillus ClausiiDRUG

For 5 days

1
Oral rehydration therapyOTHER

For 5 days

2

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Mumbai, India

Location

MeSH Terms

Conditions

Gastroenteritis

Interventions

clausin peptide, Bacillus clausiiFluid Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Shah Pratik

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 5, 2007

First Posted

April 6, 2007

Study Start

March 1, 2007

Primary Completion

December 1, 2007

Last Updated

January 21, 2009

Record last verified: 2009-01

Locations

IN(1)