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Efficacy of Two Probiotic Preparations in Children With Acute Diarrhoea

Primary Purpose

Gastroenteritis

Status
Withdrawn
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Saccharomyces boulardii
Probiotics combination
Placebo
Sponsored by
Sinaloa Pediatric Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroenteritis focused on measuring Gastroenteritis, diarrhea

Eligibility Criteria

1 Month - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sinaloa Pediatric Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Saccharomyces boulardii

Probiotics combination

Placebo

Arm Description

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

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 sachet. One sachet orally, BID, for 5 days.

Outcomes

Primary Outcome Measures

Duration of diarrhoea in hours

Secondary Outcome Measures

Percentage of children requiring hospitalisation
Adverse effects
Number of liquid stools

Full Information

First Posted
March 4, 2014
Last Updated
September 4, 2018
Sponsor
Sinaloa Pediatric Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02080130
Brief Title
Efficacy of Two Probiotic Preparations in Children With Acute Diarrhoea
Official Title
Efficacy of Two Probiotic Preparations in Children With Acute Viral Diarrhoea, Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Withdrawn
Why Stopped
No participants.
Study Start Date
February 2014 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sinaloa Pediatric Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroenteritis
Keywords
Gastroenteritis, diarrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Saccharomyces boulardii
Arm Type
Experimental
Arm Description
FLORATIL®. Saccharomyces boulardii 200 mg sachet. One sachet orally, BID, for 5 days.
Arm Title
Probiotics combination
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo sachet. One sachet orally, BID, for 5 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Saccharomyces boulardii
Intervention Description
FLORATIL®. Saccharomyces boulardii 200 mg sachet. One sachet orally, BID, for 5 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotics combination
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Duration of diarrhoea in hours
Time Frame
Up to 7 days
Secondary Outcome Measure Information:
Title
Percentage of children requiring hospitalisation
Time Frame
Up to 7 days
Title
Adverse effects
Time Frame
Up to 7 days
Title
Number of liquid stools
Time Frame
Up to seven days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giordano Pérez-Gaxiola, MD
Organizational Affiliation
Sinaloa Pediatric Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Sinaloa Pediatric Hospital
City
Culiacan
State/Province
Sinaloa
ZIP/Postal Code
80200
Country
Mexico

12. IPD Sharing Statement

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Efficacy of Two Probiotic Preparations in Children With Acute Diarrhoea

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