Nitazoxanide for the Treatment of Prolonged Diarrhea in Children

Study Overview
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Brief Summary
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The purpose of this study was to determine the efficacy of nitazoxanide suspension compared to placebo in treating prolonged diarrhea in children.

Official Title
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Multi-Center, Double-Blind, Placebo-Controlled Study of Nitazoxanide Suspension in the Treatment of Prolonged Diarrhea in Children

Conditions
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Diarrhea

Intervention / Treatment
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* Drug: Nitazoxanide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with diarrhea ≥3 days but <30 days duration. No visible blood in stool. Exclusion Criteria: Use of any antibacterial, antiparasitic or antiviral drugs within 5 days of enrollment. Females who are pregnant, suspected of being pregnant or breastfeeding. Serious systemic disorders incompatible with the study. History of hypersensitivity to nitazoxanide. Patients in whom the possibility of receiving placebo and not being able to receive immediately an effective treatment will be incompatible with the severity of the patient's illness according to the investigator's judgment. Patients known to have or suspected of having AIDS or other immune deficiencies.

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nitazoxanide Suspension<br>Nitazoxanide Oral Suspension 100 mg/5 ml for patients aged 1-3 years or Nitazoxanide Oral Suspension 200 mg/10 ml for patients aged 4-11 years | Drug: Nitazoxanide<br>* Nitazoxanide Oral Suspension 100 mg/5 ml for patients aged 1-3 years twice daily for 3 days or Nitazoxanide Oral Suspension 200 mg/10 ml for patients aged 4-11 years twice daily for 3 days<br>* Other names: Alinia;|
| Placebo Comparator: Placebo Suspension<br>Placebo Oral Suspension 5 ml for patients aged 1-3 years and Placebo Oral Suspension 10 ml for patients aged 4-11 years | Drug: Nitazoxanide<br>* Nitazoxanide Oral Suspension 100 mg/5 ml for patients aged 1-3 years twice daily for 3 days or Nitazoxanide Oral Suspension 200 mg/10 ml for patients aged 4-11 years twice daily for 3 days<br>* Other names: Alinia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from first dose to resolution of symptoms | Resolution of symptoms defined as resolution of all gastrointestinal symptoms associated with prolonged diarrhea at enrollment including abdominal pain or tenderness, distention, etc. with the patient not requiring anti-motility or other palliative treatment. Symptom resolution must be maintained for at least 72 hours to be considered valid. | Up to 17 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diarrhea