Use of Nitazoxanide and Probiotics in Acute Diarrhea Secondary to Rotavirus

Centro Pediatrico Albina de Patino

Status: Completed

Conditions: Diarrhea; Rotavirus Infection

Treatments: Other: Oral hydration solutions; Drug: Nitazoxanide; Drug: Probiotic mix preparation

Study type: Interventional

Funder types: Other

Identifiers

NCT00683982

PROT261179

PROT261179B

Details and patient eligibility

About

Nitazoxanide has proved an cytoprotective effect against rotavirus infection. How it could be clinically important in time of hospitalization and reduction of duration of diarrhea secondary to rotavirus?

Full description

Nitazoxanide has demonstrated a cytoprotective effect against rotavirus, reducing duration time of diarrhea in comparison to placebo in previous studies. In the current study, based in those results, we design a randomized single-blind controlled trial, in order to asses the effectiveness of nitazoxanide and probiotics in comparison with a control group

Enrollment: 75 patients

Sex: All

Ages: 28 days to 24 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Positive stool sample for rotavirus test

Exclusion criteria

• Severe malnourishment
• Severe dehydration
• History of diarrhea more than 3 days previous hospitalization
• Use of antibiotics, probiotics or nitazoxanide 3 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: Single Blind

---

75 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

This group will receive oral nitazoxanide preparation

Treatment:

Drug: Nitazoxanide

2

Active Comparator group

Description:

This group will receive a mix combination of probiotics

Treatment:

Drug: Probiotic mix preparation

3

Placebo Comparator group

Description:

This is the control group receiving only oral or systemic hydration solutions

Treatment:

Other: Oral hydration solutions