Use of Probiotic Yogurt in the Treatment of Acute Diarrhea in Children

Acute Gastroenteritis Clinical Trial

Official title:

Use of Probiotic Yogurt in the Treatment of Acute Diarrhea in Children: A Randomized Double-blind Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01564290
• Other study ID #: protprobiot2010
• Status: Completed
• Phase: Phase 4
• First received: October 29, 2011
• Last updated: March 26, 2012
• Start date: February 2011
• Est. completion date: February 2012

Study information

• Verified date: March 2012
• Source: Centro Pediatrico Albina de Patino
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bolivia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effect of probiotic yogurt in acute watery diarrhea in children. The investigators will compare the effect of two different probiotics products.

Description:

Background: Acute Gastroenteritis is one of the most and frequent disease in the childhood, considering the advances in treatment, Lactobacillus Rahmnosus has being well described as a probiotic who reduces the number of days of hospitalization and also de the severity.

Objectives: To evaluate the effect of the probiotic yogurt in the treatment of children who are between 10 months and 3 years old with acute non-dysenteric diarrhea.

Methods: A randomized clinical trial, controlled, double-blind. The investigators will have two groups of patients : One group will receive Lactobacillus Rahmnosus in a yogurt presentation and the other one will receive Sacharomyces boulardii in a lyophilized form ; the parameters of evaluation are going to be the number of diarrhea stools by day, number of vomiting episodes, hours with fever, nutritional and immunization state.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: February 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Months to 36 Months

Eligibility

Inclusion Criteria:

• All acute diarrhea

Exclusion Criteria:

• Severe malnourishment

• Severe dehydration

• Systemic infections

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Diarrhea
• Acute Gastroenteritis
• Diarrhea
• Gastroenteritis

Intervention

Dietary Supplement:
• Probiotic yogurt
Lactobacilus Rhamnonsus 100000000 UFC per mL. Dosage 50 mL twice daily fo 5 days.

Drug:
• Placebo probiotic
Lyophilized probiotic, containing 250 mg per sachet dosage to about 2 times a day for 5 days.

Locations

Country	Name	City	State
Bolivia	Centro Pediatrico Albina Patino	Cochabamba

Sponsors (1)

Lead Sponsor	Collaborator
Centro Pediatrico Albina de Patino

Country where clinical trial is conducted

Bolivia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of diarrhea	participants will be followed for the duration of hospital stay, an expected average of 5 days	five days	Yes
Secondary	Duration of fever	participants will be followed for the duration of hospital stay, an expected average of 5 days	five days	Yes
Secondary	duration of vomiting	participants will be followed for the duration of hospital stay, an expected average of 5 days	five days	Yes
Secondary	duration of hospitalization	participants will be followed for the duration of hospital stay, an expected average of 5 days	five days	Yes