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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 22, 2014