# Randomized Control Trial of Nitazoxanide for the Treatment of Cryptosporidium Infection in Malnourished Children in Bangladesh

> **NIH NIH U01** · JOHNS HOPKINS UNIVERSITY · 2024 · $718,217

## Abstract

Project Summary
Cryptosporidiosis is a leading contributor to child morbidity and mortality worldwide, responsible
for over 200,000 deaths in children under two, and morbidity in over 7 million children. However,
we have limited treatment and no vaccine for use in young children. Our prior work in
Bangladesh has demonstrated that almost 80% of children in an urban slum cohort were
infected with Cryptosporidium spp. by age two and that infection, even without diarrhea, was
significantly associated with long-term growth faltering. Nitazoxanide is the only FDA-approved
drug for treatment of Cryptosporidium diarrheal disease. However, the drug has limited
widespread due to lack of large-scale, unbiased rigorous trials demonstrating its efficacy in
children under one and establishing its safety in this population. Furthermore, little is known
about how the drug could treat non-diarrheal infection and alleviate Cryptosporidium’s effect on
child growth.
Here we propose a double-blind, randomized, placebo-controlled trial aimed at treating children
ages 6-12 months with Cryptosporidium-diarrheal and non-diarrheal infection. The study will
evaluate the efficacy of treatment for both conditions and will also evaluate whether treatment
can improve growth in children for 6 months post-treatment.
This proposal leverages a longstanding collaboration between Johns Hopkins University and the
International Centre for Diarrhoeal Disease, Research, Bangladesh. This proposal is innovative,
as it will be the first randomized controlled trial aimed at treatment of non-diarrheal
Cryptosporidium infection and will evaluate impact on growth. The findings from this study will
inform treatment efforts aid to protect young children from this devastating infectious disease.

## Key facts

- **NIH application ID:** 10845461
- **Project number:** 5U01AI167788-02
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** Poonum S. Korpe
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $718,217
- **Award type:** 5
- **Project period:** 2023-05-22 → 2028-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10845461

## Citation

> US National Institutes of Health, RePORTER application 10845461, Randomized Control Trial of Nitazoxanide for the Treatment of Cryptosporidium Infection in Malnourished Children in Bangladesh (5U01AI167788-02). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10845461. Licensed CC0.

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