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
  Purpose

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.


Condition Intervention Phase
Acute Diarrhea
Acute Gastroenteritis
Dietary Supplement: Probiotic yogurt
Drug: Placebo probiotic
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Probiotic Yogurt in the Treatment of Acute Diarrhea in Children: A Randomized Double-blind Trial

Resource links provided by NLM:


Further study details as provided by Centro Pediatrico Albina de Patino:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 54
Study Start Date: February 2011
Study Completion Date: February 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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.

  Eligibility

Ages Eligible for Study:   10 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All acute diarrhea

Exclusion Criteria:

  • Severe malnourishment
  • Severe dehydration
  • Systemic infections
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01564290

Locations
Bolivia
Centro Pediatrico Albina Patino
Cochabamba, Bolivia, 0866
Sponsors and Collaborators
Centro Pediatrico Albina de Patino
Investigators
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
  More Information

No publications provided

Responsible Party: Carlos Teran, Teaching and Research chief, Centro Pediatrico Albina de Patino
ClinicalTrials.gov Identifier: NCT01564290     History of Changes
Other Study ID Numbers: protprobiot2010
Study First Received: October 29, 2011
Last Updated: March 26, 2012
Health Authority: Bolivia: Ethics Committee

Keywords provided by Centro Pediatrico Albina de Patino:
acute diarrhea
probiotics
children

Additional relevant MeSH terms:
Diarrhea
Gastroenteritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 30, 2014