Diarrhea
Conditions
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: * To evaluate the clinical safety of the Bacillus clausii probiotic strain versus placebo.
Interventions
DRUGSpores of Bacillus Clausii Probiotic Strain
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
6 Months to 36 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Belgium, France
Outcome results
None listed