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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carlos Teran, Centro Pediatrico Albina de Patino
ClinicalTrials.gov Identifier:
NCT01564290
First received: October 29, 2011
Last updated: March 26, 2012
Last verified: March 2012

October 29, 2011
March 26, 2012
February 2011
August 2011   (final data collection date for primary outcome measure)
Duration of diarrhea [ Time Frame: five days ] [ Designated as safety issue: Yes ]
participants will be followed for the duration of hospital stay, an expected average of 5 days
Same as current
Complete list of historical versions of study NCT01564290 on ClinicalTrials.gov Archive Site
  • Duration of fever [ Time Frame: five days ] [ Designated as safety issue: Yes ]
    participants will be followed for the duration of hospital stay, an expected average of 5 days
  • duration of vomiting [ Time Frame: five days ] [ Designated as safety issue: Yes ]
    participants will be followed for the duration of hospital stay, an expected average of 5 days
  • duration of hospitalization [ Time Frame: five days ] [ Designated as safety issue: Yes ]
    participants will be followed for the duration of hospital stay, an expected average of 5 days
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Acute Diarrhea
  • Acute Gastroenteritis
  • 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.
    Other Name: Florestor
  • Placebo Comparator: probiotic
    Probiotic product with Sacharomices Boulardii
    Intervention: Drug: Placebo probiotic
  • Active Comparator: probiotic yogurt
    Yogurt with Lactobacilus Rhamnonsus strain spp
    Intervention: Dietary Supplement: Probiotic yogurt
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
February 2012
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All acute diarrhea

Exclusion Criteria:

  • Severe malnourishment
  • Severe dehydration
  • Systemic infections
Both
10 Months to 36 Months
No
Contact information is only displayed when the study is recruiting subjects
Bolivia
 
NCT01564290
protprobiot2010
No
Carlos Teran, Centro Pediatrico Albina de Patino
Centro Pediatrico Albina de Patino
Not Provided
Principal Investigator: Giuseppe E Grandy, MD MSc Centro Pediatrico Albina Patino
Study Director: Richard M Soria, MD Centro Pediatrico Albina Patino
Study Chair: Sdenka Jose, MD Centro Pediatrico Albina Patino
Centro Pediatrico Albina de Patino
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP