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Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00981877
Enrollment
76
Registered
2009-09-22
Start date
2007-07-31
Completion date
2008-03-31
Last updated
2009-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diarrhea, Rotavirus Infection

Keywords

acute diarrhea, rotavirus, probiotic, children

Brief 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.

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.

Interventions

DRUGGB (Florestor)

S. Boulardii preparation of 1 gram twice daily for 5 days

DRUGGRALB

mixed probiotic preparation 1 gram twice daily for 5 days.

DRUGGC (placebo)

Placebo 1 gram twice daily for 5 days.

Sponsors

Instituto de Nutrición y Tecnología de los Alimentos
CollaboratorOTHER
Centro Pediatrico Albina de Patino
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
1 Months to 23 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Duration of diarrheawithin the first 72 hours during hospitalization

Secondary

MeasureTime frame
Duration of feverthe first 72 hours during hospitalization
Duration of vomitingthe first 72 hours during hospitalization
Duration of hospitalization4 days

Countries

Bolivia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026