TEDDY: Spores of Bacillus Clausii in Acute Diarrhoea in Children

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi

Criteria

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