Efficacy of Two Probiotic Preparations in Children With Acute Diarrhoea
NCT02080130 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2018-09-06
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.
Conditions
Interventions
- 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
Sponsors & Collaborators
-
Sinaloa Pediatric Hospital
lead OTHER
Principal Investigators
-
Giordano Pérez-Gaxiola, MD · Sinaloa Pediatric Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 1 Month
- Max Age
- 5 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-02-28
- Primary Completion
- 2016-10-31
- Completion
- 2016-12-31
Countries
- Mexico
Study Locations
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