Back to resultsUse of Probiotic Yogurt in the Treatment of Acute Diarrhea in Children
Primary Purpose
Acute Diarrhea, Acute Gastroenteritis
Status
Completed
Phase
Phase 4
Locations
Bolivia
Study Type
Interventional
Intervention
Probiotic yogurt
Placebo probiotic
Sponsored by
About this trial
This is an interventional treatment trial for Acute Diarrhea focused on measuring acute diarrhea, probiotics, children
Eligibility Criteria
Inclusion Criteria:
- All acute diarrhea
Exclusion Criteria:
- Severe malnourishment
- Severe dehydration
- Systemic infections
Sites / Locations
- Centro Pediatrico Albina Patino
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
probiotic
probiotic yogurt
Arm Description
Probiotic product with Sacharomices Boulardii
Yogurt with Lactobacilus Rhamnonsus strain spp
Outcomes
Primary Outcome Measures
Duration of diarrhea
participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary Outcome Measures
Duration of fever
participants will be followed for the duration of hospital stay, an expected average of 5 days
duration of vomiting
participants will be followed for the duration of hospital stay, an expected average of 5 days
duration of hospitalization
participants will be followed for the duration of hospital stay, an expected average of 5 days
Full Information
NCT ID
NCT01564290
First Posted
October 29, 2011
Last Updated
March 26, 2012
Sponsor
Centro Pediatrico Albina de Patino
1. Study Identification
Unique Protocol Identification Number
NCT01564290
Brief Title
Use of Probiotic Yogurt in the Treatment of Acute Diarrhea in Children
Official Title
Use of Probiotic Yogurt in the Treatment of Acute Diarrhea in Children: A Randomized Double-blind Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Pediatrico Albina de Patino
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Diarrhea, Acute Gastroenteritis
Keywords
acute diarrhea, probiotics, children
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
probiotic
Arm Type
Placebo Comparator
Arm Description
Probiotic product with Sacharomices Boulardii
Arm Title
probiotic yogurt
Arm Type
Active Comparator
Arm Description
Yogurt with Lactobacilus Rhamnonsus strain spp
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic yogurt
Intervention Description
Lactobacilus Rhamnonsus 100000000 UFC per mL. Dosage 50 mL twice daily fo 5 days.
Intervention Type
Drug
Intervention Name(s)
Placebo probiotic
Other Intervention Name(s)
Florestor
Intervention Description
Lyophilized probiotic, containing 250 mg per sachet dosage to about 2 times a day for 5 days.
Primary Outcome Measure Information:
Title
Duration of diarrhea
Description
participants will be followed for the duration of hospital stay, an expected average of 5 days
Time Frame
five days
Secondary Outcome Measure Information:
Title
Duration of fever
Description
participants will be followed for the duration of hospital stay, an expected average of 5 days
Time Frame
five days
Title
duration of vomiting
Description
participants will be followed for the duration of hospital stay, an expected average of 5 days
Time Frame
five days
Title
duration of hospitalization
Description
participants will be followed for the duration of hospital stay, an expected average of 5 days
Time Frame
five days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All acute diarrhea
Exclusion Criteria:
Severe malnourishment
Severe dehydration
Systemic infections
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe E Grandy, MD MSc
Organizational Affiliation
Centro Pediatrico Albina Patino
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard M Soria, MD
Organizational Affiliation
Centro Pediatrico Albina Patino
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sdenka Jose, MD
Organizational Affiliation
Centro Pediatrico Albina Patino
Official's Role
Study Chair
Facility Information:
Facility Name
Centro Pediatrico Albina Patino
City
Cochabamba
ZIP/Postal Code
0866
Country
Bolivia
12. IPD Sharing Statement
Learn more about this trial
Use of Probiotic Yogurt in the Treatment of Acute Diarrhea in Children
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