NCT00265369

Brief Summary

Primary objective:

  • To demonstrate the efficacy of a Bacillus clausii probiotic strain compared to placebo in children suffering from acute diarrhoea and treated for 7 days. Secondary objective:
  • To evaluate the clinical safety of the Bacillus clausii probiotic strain versus placebo.

Trial Health

85
On Track

Trial Health Score

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

Enrollment
420

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
2 countries

2 active sites

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

May 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2005

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 14, 2005

Completed
Last Updated

January 11, 2011

Status Verified

January 1, 2011

First QC Date

November 4, 2005

Last Update Submit

January 10, 2011

Conditions

Diarrhea

Outcome Measures

Primary Outcomes (1)

  • Duration of diarrhoea as counted from the first intake of the investigational product up to the first appearance of a loose stool followed by two-consecutive normal stools

Secondary Outcomes (1)

  • Number of infants/children with normal stools at D3, D4, D5, D6 and D7;Mean number of stools per day;Occurrence of vomiting episodes per day after enrolment;Parents'overall global assessment of efficacy at the end of the treatment;other safety criteria

Interventions

Spores of Bacillus Clausii Probiotic StrainDRUG

Eligibility Criteria

Age6 Months - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants or Children
  • Non hospitalized infants or children
  • With acute diarrhea evident for less than 48 hours
  • Having had three or more watery stools during the preceding 24 hours

You may not qualify if:

  • Infants or Children
  • With blood stools
  • Having been treated with antibiotics or probiotics within the two weeks before the enrollment
  • Suffering from dehydration defined by a weight loss of at least 5% or by the presence of a skin fold
  • With an history of seizures
  • With immunosuppressive conditions
  • With a current status requiring an antibiotic treatment
  • Suffering from a chronic disease including chronic diarrhea whatever the origin
  • Probiotics
  • Prebiotics
  • Drugs with adsorbing properties
  • Drugs that modify intestinal secretion like bismuth subsalicylate, acetorphan
  • Drugs that modify intestinal motility (opiates such as loperamide, atropine and other cholinergic agents).
  • Having participated in another clinical trial in the last 3 months prior to the start of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sanofi-Aventis

Brussels, Belgium

Location

Sanofi-Aventis

Paris, France

Location

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gilles Perdriset, MD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 4, 2005

First Posted

December 14, 2005

Study Start

May 1, 2004

Last Updated

January 11, 2011

Record last verified: 2011-01

Locations

FR(1)BE(1)