TEDDY: Spores of Bacillus Clausii in Acute Diarrhoea in Children

Sanofi

Status and phase: Completed; Phase 3

Conditions: Diarrhea

Treatments: Drug: Spores of Bacillus Clausii Probiotic Strain

Study type: Interventional

Funder types: Industry

Identifiers

NCT00265369

C_9240

Details and patient eligibility

About

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.

Sex: All

Ages: 6 to 36 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind