Efficacy of Two Probiotic Preparations in Children With Acute Diarrhoea

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02080130

Enrollment

Registered

2014-03-06

Start date

2014-02-28

Completion date

2016-12-31

Last updated

2018-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroenteritis

Keywords

Gastroenteritis, diarrhea

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.

Interventions

DIETARY_SUPPLEMENTSaccharomyces boulardii

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

DIETARY_SUPPLEMENTProbiotics 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

OTHERPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Months to 5 Years

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

Design outcomes

Primary

Measure	Time frame
Duration of diarrhoea in hours	Up to 7 days

Secondary

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

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026