Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children

This study has been completed.
Sponsor:
Collaborator:
Instituto de Nutricion y Tecnologia de los Alimentos
Information provided by:
Centro Pediatrico Albina de Patino
ClinicalTrials.gov Identifier:
NCT00981877
First received: September 18, 2009
Last updated: September 21, 2009
Last verified: September 2009
  Purpose

The purpose of this study is to determine the effect of probiotics in rotavirus acute diarrhea in children. The investigators will compare the effect of two different probiotics products.


Condition Intervention
Diarrhea
Rotavirus Infection
Drug: GB (Florestor)
Drug: GRALB
Drug: GC (placebo)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children: Randomized Double-blind, Controlled Trial Using Two Different Preparations

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Duration of diarrhea [ Time Frame: within the first 72 hours during hospitalization ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of fever [ Time Frame: the first 72 hours during hospitalization ] [ Designated as safety issue: Yes ]
  • Duration of vomiting [ Time Frame: the first 72 hours during hospitalization ] [ Designated as safety issue: Yes ]
  • Duration of hospitalization [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: July 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
This group will receive S. Boulardii Probiotic and Oral rehydration as needed
Drug: GB (Florestor)
S. Boulardii preparation of 1 gram twice daily for 5 days
Other Name: Florestor, Bioflora
Active Comparator: 2
This group will receive a mixed Probiotic preparation and oral rehydration as needed
Drug: GRALB
mixed probiotic preparation 1 gram twice daily for 5 days.
Other Name: Probiotik, mixed probiotic
Placebo Comparator: 3
This group will receive a placebo, and oral rehydration as needed
Drug: GC (placebo)
Placebo 1 gram twice daily for 5 days.
Other Name: Placebo

Detailed Description:

Acute diarrhea remains being the second most frequent infectious condition in children, producing a high number of admissions yearly. In children below one year of age, rotavirus represents the main etiologic agent, both in developed and developing countries. In Bolivia, acute diarrhea affects about 30% of the group below 5 years of age. Probiotics appear as one of the alternatives currently under discussion. Also, evidence available suggests that probiotics shorten the time of diarrhea and therefore the time of rotavirus excretion. In daily practice, we are often limited by the type and number of probiotics products locally available; moreover, information about combined products is scarce. With this in mind, in this study we compared the efficacy of two commercially available products.

  Eligibility

Ages Eligible for Study:   1 Month to 23 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Positive stool sample for rotavirus test

Exclusion Criteria:

  • Severe malnourishment
  • Severe dehydration
  • Use of antibiotics, probiotics or nitazoxanide 2 weeks before admission
  • Systemic infections
  • Severe chronic disease
  • Mixed enteric infections besides rotavirus
  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: NCT00981877

Locations
Bolivia
Centro Pediatrico Albina Patino
Cochabamba, Bolivia
Sponsors and Collaborators
Centro Pediatrico Albina de Patino
Instituto de Nutricion y Tecnologia de los Alimentos
Investigators
Study Director: Richard M Soria, MD Centro Pediatrico Albina Patino
Principal Investigator: Giuseppe E Grandy, Md Centro Pediatrico Albina Patino - Instituto de Nutricion y Tecnologia de los Alimentos
  More Information

No publications provided by Centro Pediatrico Albina de Patino

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Giuseppe Grandy Aranda, Centro Pediatrico Albina de Patino/ Departamento de Gastroenterologia y Nutricion
ClinicalTrials.gov Identifier: NCT00981877     History of Changes
Other Study ID Numbers: protrota2007
Study First Received: September 18, 2009
Last Updated: September 21, 2009
Health Authority: Bolivia: Ministry of Health

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

Additional relevant MeSH terms:
Diarrhea
Rotavirus Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Reoviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on July 24, 2014