TEDDY: Spores of Bacillus Clausii in Acute Diarrhoea in Children

Diarrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00265369
• Other study ID #: C_9240
• Status: Completed
• Phase: Phase 3
• First received: November 4, 2005
• Last updated: January 10, 2011
• Start date: May 2004

Study information

• Verified date: January 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 36 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diarrhea

Intervention

Drug:
• Spores of Bacillus Clausii Probiotic Strain

Locations

Country	Name	City	State
Belgium	Sanofi-Aventis	Brussels
France	Sanofi-Aventis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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