Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children

Centro Pediatrico Albina de Patino

Status: Completed

Conditions: Diarrhea; Rotavirus Infection

Treatments: Drug: GC (placebo); Drug: GB (Florestor); Drug: GRALB

Study type: Interventional

Funder types: Other

Identifiers

NCT00981877

protrota2007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 1 to 23 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

76 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

This group will receive S. Boulardii Probiotic and Oral rehydration as needed

Treatment:

Drug: GB (Florestor)

2

Active Comparator group

Description:

This group will receive a mixed Probiotic preparation and oral rehydration as needed

Treatment:

Drug: GRALB

3

Placebo Comparator group

Description:

This group will receive a placebo, and oral rehydration as needed

Treatment:

Drug: GC (placebo)