Status:
COMPLETED
TEDDY: Spores of Bacillus Clausii in Acute Diarrhoea in Children
Lead Sponsor:
Sanofi
Conditions:
Diarrhea
Eligibility:
All Genders
6-36 years
Phase:
PHASE3
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: *...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT00265369
Start Date
May 1 2004
Last Update
January 11 2011
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Sanofi-Aventis
Brussels, Belgium
2
Sanofi-Aventis
Paris, France