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TEDDY: Spores of Bacillus Clausii in Acute Diarrhoea in Children

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00265369
First received: November 4, 2005
Last updated: January 10, 2011
Last verified: January 2011
History of Changes
  Purpose

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.

Condition Intervention Phase
Diarrhea
 Drug: Spores of Bacillus Clausii Probiotic Strain
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Comparative Efficacy and Safety of a Bacillus Clausii Probiotic Strain Versus Placebo in the Treatment of Acute Diarrhoea in Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Estimated Enrollment: 420
Study Start Date: May 2004
  Eligibility

Ages Eligible for Study:   6 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

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

Exclusion criteria:

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

  • Having received before inclusion one of the following treatments:

    • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00265369

Locations
Belgium
Sanofi-Aventis
Brussels, Belgium
France
Sanofi-Aventis
Paris, France
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Gilles Perdriset, MD Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00265369     History of Changes
Other Study ID Numbers: C_9240
Study First Received: November 4, 2005
Last Updated: January 10, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013