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Spores of Bacillus Clausii Probiotic Strain

Phase 3

Diarrhea | Small molecule | Gastrointestinal |Sanofi|Last Updated: Jan 11, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment420

FDA Designations

No designations recorded

Clinical trial landscape

Spores of Bacillus Clausii Probiotic Strain · 1 trial · 1 indication

Phase 3 1
NCT00265369TEDDY: Spores of Bacillus Clausii in Acute Diarrhoea in ChildrenDiarrhea
COMPLETED420 Analytics
PHASE3COMPLETED
TEDDY: Spores of Bacillus Clausii in Acute Diarrhoea in Children
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Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Spores of Bacillus Clausii Probiotic StrainDRUG -
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Eligibility Criteria

Age Range6 Months to 36 Months
SexALL
Healthy VolunteersNo
Study Sites2

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 antib...

Countries:BelgiumFrance
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Frequently asked questions about Spores of Bacillus Clausii Probiotic Strain

What is Spores of Bacillus Clausii Probiotic Strain used for?

Spores of Bacillus Clausii Probiotic Strain is an investigational probiotic being studied for the treatment of diarrhea. It is currently in Phase 3 clinical development and has been evaluated in a completed trial involving children with acute diarrhea.

Who makes Spores of Bacillus Clausii Probiotic Strain?

Spores of Bacillus Clausii Probiotic Strain is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY.

What phase is Spores of Bacillus Clausii Probiotic Strain in?

Spores of Bacillus Clausii Probiotic Strain is in Phase 3 clinical development. It is an investigational product and has not been approved by regulatory authorities. A Phase 3 trial has been completed, but the product remains under investigation.

What clinical trials is Spores of Bacillus Clausii Probiotic Strain in?

Spores of Bacillus Clausii Probiotic Strain has one completed Phase 3 trial, NCT00265369, titled 'TEDDY: Spores of Bacillus Clausii in Acute Diarrhoea in Children'. This randomized, double-blind study enrolled 420 participants in Belgium and France.

Is Spores of Bacillus Clausii Probiotic Strain the same as Bacillus Clausii?

Spores of Bacillus Clausii Probiotic Strain refers to the probiotic formulation containing spores of the bacterium Bacillus clausii. The trial NCT00265369 specifically studied this strain in the context of acute diarrhea in children.