NCT02080130

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• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sinaloa Pediatric Hospital · Academic / Other
• Sex: All
• Age: 1 Month – 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastroenteritis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Saccharomyces boulardii	FLORATIL®. Saccharomyces boulardii 200 mg sachet. One sachet orally, BID, for 5 days.
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
OTHER	Placebo	Placebo

Timeline

• Start date: 2014-02-01
• Primary completion: 2016-10-01
• Completion: 2016-12-01
• First posted: 2014-03-06
• Last updated: 2018-09-06

Locations

1 site across 1 country: Mexico