TEDDY: Spores of Bacillus Clausii in Acute Diarrhoea in Children

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.

Completed

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Key information

Conditions

Diarrhea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

6 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis, Brussels, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spores of Bacillus Clausii Probiotic Strain

Drug

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start: 2004
First posted: Dec 14, 2005
Registry last updated: Jan 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed