Efficacy of Two Probiotic Preparations in Children With Acute Diarrhoea

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gastroenteritis

Intervention / Treatment
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* Dietary Supplement: Saccharomyces boulardii
* Dietary Supplement: Probiotics combination
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Saccharomyces boulardii<br>FLORATIL®. Saccharomyces boulardii 200 mg sachet. One sachet orally, BID, for 5 days. | Dietary Supplement: Saccharomyces boulardii<br>* FLORATIL®. Saccharomyces boulardii 200 mg sachet. One sachet orally, BID, for 5 days.<br>|
| Experimental: Probiotics combination<br>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<br>* 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<br>|
| Placebo Comparator: Placebo<br>Placebo sachet. One sachet orally, BID, for 5 days. | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of diarrhoea in hours |  | Up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diarrhea, Gastroenteritis