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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01564290
Other study ID # protprobiot2010
Secondary ID
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


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
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