Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children

Diarrhea Clinical Trial

Official title:

Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children: Randomized Double-blind, Controlled Trial Using Two Different Preparations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00981877
• Other study ID #: protrota2007
• Status: Completed
• Phase: N/A
• First received: September 18, 2009
• Last updated: September 21, 2009
• Start date: July 2007
• Est. completion date: March 2008

Study information

• Verified date: September 2009
• Source: Centro Pediatrico Albina de Patino
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bolivia: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 23 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diarrhea
• Rotavirus Infection
• Rotavirus Infections

Intervention

Drug:
• GB (Florestor)
S. Boulardii preparation of 1 gram twice daily for 5 days
• GRALB
mixed probiotic preparation 1 gram twice daily for 5 days.
• GC (placebo)
Placebo 1 gram twice daily for 5 days.

Locations

Country	Name	City	State
Bolivia	Centro Pediatrico Albina Patino	Cochabamba

Sponsors (2)

Lead Sponsor	Collaborator
Centro Pediatrico Albina de Patino	Instituto de Nutrición y Tecnología de los Alimentos

Country where clinical trial is conducted

Bolivia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of diarrhea		within the first 72 hours during hospitalization	Yes
Secondary	Duration of fever		the first 72 hours during hospitalization	Yes
Secondary	Duration of vomiting		the first 72 hours during hospitalization	Yes
Secondary	Duration of hospitalization		4 days	No