TEDDY: Spores of Bacillus Clausii in Acute Diarrhoea in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Spores of Bacillus Clausii Probiotic Strain

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No