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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Gastroenteritis; Acute Diarrhea
• Intervention / Treatment: Drug: Placebo probiotic; Dietary supplement: Probiotic yogurt

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 4

Contacts and Locations

Study Locations

• Bolivia
  • Cochabamba, Bolivia, 0866
    • Centro Pediatrico Albina Patino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 months to 3 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All acute diarrhea

Exclusion Criteria:

• Severe malnourishment
• Severe dehydration
• Systemic infections

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: probiotic; Probiotic product with Sacharomices Boulardii	Drug: Placebo probiotic; Lyophilized probiotic, containing 250 mg per sachet dosage to about 2 times a day for 5 days.; Other Names: Florestor
ACTIVE_COMPARATOR: probiotic yogurt; Yogurt with Lactobacilus Rhamnonsus strain spp	Dietary supplement: Probiotic yogurt; Lactobacilus Rhamnonsus 100000000 UFC per mL. Dosage 50 mL twice daily fo 5 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of diarrhea	participants will be followed for the duration of hospital stay, an expected average of 5 days	five days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of fever	participants will be followed for the duration of hospital stay, an expected average of 5 days	five days
duration of vomiting	participants will be followed for the duration of hospital stay, an expected average of 5 days	five days
duration of hospitalization	participants will be followed for the duration of hospital stay, an expected average of 5 days	five days

Collaborators and Investigators

• Sponsor: Centro Pediatrico Albina de Patino
• Investigators: Principal Investigator: Giuseppe E Grandy, MD MSc, Centro Pediatrico Albina Patino; Study Chair: Sdenka Jose, MD, Centro Pediatrico Albina Patino

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (ACTUAL): August 1, 2011
• Study Completion (ACTUAL): February 1, 2012

Study Registration Dates

• First Submitted: October 29, 2011
• First Submitted That Met QC Criteria: March 26, 2012
• First Posted (ESTIMATE): March 27, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): March 27, 2012
• Last Update Submitted That Met QC Criteria: March 26, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: children; probiotics; acute diarrhea
• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Diarrhea; Gastroenteritis
• Other Study ID Numbers: protprobiot2010