Efficacy of Two Probiotic Preparations in Children With Acute Diarrhoea

Not Applicable

Withdrawn

• Conditions: Gastroenteritis
• Interventions: Other: Placebo; Dietary Supplement: Saccharomyces boulardii; Dietary Supplement: Probiotics combination

• Registration Number: NCT02080130
• Lead Sponsor: Sinaloa Pediatric Hospital

Brief Summary

The purpose of this study is to determine which of two different preparations of probiotics is effective in the treatment of acute viral diarrhoea in children.

Detailed Description

Children and infants, aged 1 month to 5 years, with acute diarrhoea, will be randomised to receive either saccharomyces boulardii, a combination probiotic (Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus plantarum, Bifidobacterium infantis, Streptococcus thermophillus) or placebo, to determine if one shortens the duration of diarrhoea.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-03-04
• Study First Submitted QC: 2014-03-05
• Study First Posted: 2014-03-06
• Primary Completion: 2016-10
• Study Completion: 2016-12
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Clinical diagnosis of acute viral gastroenteritis

Exclusion Criteria

• Moderate or severe dehydration
• Malnutrition
• Immunodeficiencies
• Sepsis or bacterial infection
• Previous use of antibiotics, antidiarrheal drugs, or probiotics, in the last four weeks.
• Hospitalisation
• No phone number
• Illiteracy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo sachet. One sachet orally, BID, for 5 days.
Saccharomyces boulardii	Saccharomyces boulardii	FLORATIL®. Saccharomyces boulardii 200 mg sachet. One sachet orally, BID, for 5 days.
Probiotics combination	Probiotics combination	LACTIPAN®. Probiotics combination sachet. One sachet orally, BID, for 5 days. Lactobacillus acidophilus............. 1.00 x 109 cfu Lactobacillus casei........................ 1.00 x 109 cfu Lactobacillus rhamnosus............. 4.40 x 108 cfu Lactobacillus plantarum............... 1.76 x 108 cfu Bifidobacterium infantis................ 2.76 x 107 cfu Streptococcus thermophillus....... 6.66 x 105 cfu

Primary Outcome Measures

Name	Time	Method
Duration of diarrhoea in hours	Up to 7 days

Secondary Outcome Measures

Name	Time	Method
Adverse effects	Up to 7 days
Percentage of children requiring hospitalisation	Up to 7 days
Number of liquid stools	Up to seven days

Trial Locations

Locations (1)

Sinaloa Pediatric Hospital; 🇲🇽 Culiacan, Sinaloa, Mexico