Skip to main content
OpenTrials
Completed

NCT Number: NCT01564290

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Diarrhea Acute Gastroenteritis

Age range

10 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centro Pediatrico Albina Patino

Cochabamba, 0866, Bolivia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All acute diarrhea

Exclusion criteria

  • Severe malnourishment
  • Severe dehydration
  • Systemic infections

Treatment and study plan

Probiotic yogurt

Dietary Supplement

Lactobacilus Rhamnonsus 100000000 UFC per mL. Dosage 50 mL twice daily fo 5 days.

Placebo probiotic

Drug

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

Other names: Florestor

Primary outcomes

  1. Duration of diarrhea

    Time frame: five days

    participants will be followed for the duration of hospital stay, an expected average of 5 days

Secondary outcomes

  1. Duration of fever

    Time frame: five days

    participants will be followed for the duration of hospital stay, an expected average of 5 days

  2. duration of vomiting

    Time frame: five days

    participants will be followed for the duration of hospital stay, an expected average of 5 days

  3. duration of hospitalization

    Time frame: five days

    participants will be followed for the duration of hospital stay, an expected average of 5 days

Sponsors and collaborators

Lead sponsor

Centro Pediatrico Albina de Patino

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Mar 27, 2012
Registry last updated
Mar 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.