Efficacy of Two Probiotic Preparations in Children With Acute Diarrhoea

September 4, 2018 updated by: Giordano Perez Gaxiola, Sinaloa Pediatric Hospital

Efficacy of Two Probiotic Preparations in Children With Acute Viral Diarrhoea, Randomised Controlled Trial

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Sinaloa
      • Culiacan, Sinaloa, Mexico, 80200
        • Sinaloa Pediatric Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Saccharomyces boulardii
FLORATIL®. Saccharomyces boulardii 200 mg sachet. One sachet orally, BID, for 5 days.
Dietary supplement: Saccharomyces boulardii
FLORATIL®. Saccharomyces boulardii 200 mg sachet. One sachet orally, BID, for 5 days.
Experimental: 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
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
Placebo Comparator: Placebo
Placebo sachet. One sachet orally, BID, for 5 days.
Other: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of diarrhoea in hours
Time Frame: Up to 7 days
Up to 7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of children requiring hospitalisation
Time Frame: Up to 7 days
Up to 7 days
Adverse effects
Time Frame: Up to 7 days
Up to 7 days
Number of liquid stools
Time Frame: Up to seven days
Up to seven days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sinaloa Pediatric Hospital

Investigators

  • Study Chair: Giordano Pérez-Gaxiola, MD, Sinaloa Pediatric Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

March 4, 2014

First Submitted That Met QC Criteria

March 5, 2014

First Posted (Estimate)

March 6, 2014

Study Record Updates

Last Update Posted (Actual)

September 6, 2018

Last Update Submitted That Met QC Criteria

September 4, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPS-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastroenteritis

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe