Efficacy of Two Probiotic Preparations in Children With Acute Diarrhoea

Gastroenteritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02080130
• Other study ID #: HPS-03
• Status: Withdrawn
• Phase: N/A
• Start date: February 2014
• Est. completion date: December 2016

Study information

• Verified date: September 2018
• Source: Sinaloa Pediatric Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Diarrhea
• Gastroenteritis

Intervention

Dietary Supplement:
• Saccharomyces boulardii
FLORATIL®. Saccharomyces boulardii 200 mg sachet. One sachet orally, BID, for 5 days.
• 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

Locations

Country	Name	City	State
Mexico	Sinaloa Pediatric Hospital	Culiacan	Sinaloa

Sponsors (1)

Lead Sponsor	Collaborator
Sinaloa Pediatric Hospital

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of diarrhoea in hours		Up to 7 days
Secondary	Percentage of children requiring hospitalisation		Up to 7 days
Secondary	Adverse effects		Up to 7 days
Secondary	Number of liquid stools		Up to seven days