TEDDY: Spores of Bacillus Clausii in Acute Diarrhoea in Children - Full Text View

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 III

MedlinePlus related topics:

Diarrhea

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Comparative Efficacy and Safety of a Bacillus Clausii Probiotic Strain Versus Placebo in the Treatment of Acute Diarrhoea in Children

Further study details as provided by Sanofi-Aventis:

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

Criteria

Inclusion criteria:

Infants or Children

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

Sponsors and Collaborators

Sanofi-Aventis

Investigators


Study Director:	Gilles Perdriset, MD	Sanofi-Aventis

More Information

Study ID Numbers:	C-9240
First Received:	November 4, 2005
Last Updated:	February 11, 2008
ClinicalTrials.gov Identifier:	NCT00265369
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Signs and Symptoms

Diarrhea

Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00265369