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TEDDY: Spores of Bacillus Clausii in Acute Diarrhoea in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00265369
Recruitment Status : Completed
First Posted : December 14, 2005
Last Update Posted : January 11, 2011
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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.

Condition or disease Intervention/treatment Phase
Diarrhea Drug: Spores of Bacillus Clausii Probiotic Strain Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : May 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00265369

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Brussels, Belgium
Paris, France
Sponsors and Collaborators
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Study Director: Gilles Perdriset, MD Sanofi
Layout table for additonal information Identifier: NCT00265369    
Other Study ID Numbers: C_9240
First Posted: December 14, 2005    Key Record Dates
Last Update Posted: January 11, 2011
Last Verified: January 2011
Additional relevant MeSH terms:
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Signs and Symptoms, Digestive