Efficacy and Safety of Probiotics in the Treatment of Acute Gastroenteritis 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

PHASE4

Total Enrollment

317 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-19

Study Completion Date

2018-06-09

Brief Summary

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* Primary Objective:

o To assess the efficacy of the probiotics in reducing the duration of diarrhea in children suffering from acute gastroenteritis.
* Secondary Objectives:

* To assess the efficacy of the probiotics in improving the frequency and consistency of stools.
* To assess the efficacy of the probiotics in avoiding recurrence of diarrhea.
* To assess the efficacy of the probiotics on the disease severity.
* To assess the safety and tolerability of the studied probiotics.

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Detailed Description

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Conditions

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Acute Gastroenteritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Allocation-blinded study

Study Groups

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Saccharomyces boulardii

Floratil, 250 mg sachets, twice daily (1 in the morning and 1 in the evening) during 5 consecutive days.

Group Type ACTIVE_COMPARATOR

Probiotic : Saccharomyces boulardii

Intervention Type BIOLOGICAL

Treatment for 5 days

Bacillus clausii

Enterogermina, 5 ml vials, twice daily (1 in the morning and 1 in the evening) during 5 consecutive days.

Group Type ACTIVE_COMPARATOR

Probiotic : Bacillus clausii

Intervention Type BIOLOGICAL

Treatment for 5 days

Interventions

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Probiotic : Saccharomyces boulardii

Treatment for 5 days

Intervention Type BIOLOGICAL

Probiotic : Bacillus clausii

Treatment for 5 days

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Children of both gender aged between 6 months and 5 years
* Presenting with acute diarrhea (3 or more loose or liquid stools in a 24-hour period) since at least the last 24h but less than 5 days
* Signed informed consent of the legal representatives obtained before any study procedure
* Parents able to fulfill in the stool diary according to the physician's opinion.

Exclusion Criteria

* Unable to take medication and fluids by mouth
* More than 50% breastfeeding
* Severe malnutrition, defined by a ratio weight/height at/or below -3SD
* Severe dehydration, defined by a need of IV rehydration
* Chronic underlying disease, including but not limited to severe gastrointestinal disorder, immunocompromised condition or systemic infection
* Use of prohibited treatments
* Contra-indications to the studied probiotics

Minimum Eligible Age

6 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No