Efficacy of Two Probiotic Preparations in Children With Acute Diarrhoea

NCT02080130 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-09-06

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Saccharomyces boulardii

FLORATIL®. Saccharomyces boulardii 200 mg sachet. One sachet orally, BID, for 5 days.

DIETARY_SUPPLEMENT

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

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Sinaloa Pediatric Hospital

    lead OTHER

Principal Investigators

  • Giordano Pérez-Gaxiola, MD · Sinaloa Pediatric Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2016-10-31
Completion
2016-12-31

Countries

  • Mexico

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02080130 on ClinicalTrials.gov