Efficacy of Two Probiotic Preparations in Children With Acute Diarrhoea

Sinaloa Pediatric Hospital

Status: Withdrawn

Conditions: Gastroenteritis

Treatments: Other: Placebo; Dietary Supplement: Saccharomyces boulardii; Dietary Supplement: Probiotics combination

Study type: Interventional

Funder types: Other

Identifiers

NCT02080130

HPS-03

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 1 month to 5 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 3 patient groups, including a placebo group

Saccharomyces boulardii

Experimental group

Description:

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

Treatment:

Dietary Supplement: Saccharomyces boulardii

Probiotics combination

Experimental group

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

Treatment:

Dietary Supplement: Probiotics combination

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo