Can a 3-day pill stop deadly diarrhea in malnourished infants?
NCT ID NCT06600711
First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times
Summary
This study tests if a 3-day medicine called nitazoxanide can treat Cryptosporidium infection in 480 malnourished children aged 6-12 months in Bangladesh. The goal is to shorten diarrhea and clear the parasite from stool. Half the children get the medicine, half get a placebo, and researchers track their recovery for 6 months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 480 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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May 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 12 months
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * tests positive for Cryptosporidium by stool point-of-care test, with or without active diarrhea * family plans on remaining in the area for next 6 months Exclusion Criteria: * history of hypersensitivity to nitazoxanide. * taking warfarin. Tizoxanide, the metabolite of nitazoxanide is highly bound to plasma proteins and may compete with binding sites of other highly plasma bound drugs with narrow therapeutic indices, including warfarin. * history of renal insufficiency or a baseline serum creatinine = 40 µmol/L. Renal clearance of the drug has not been studied. * history of hepatic dysfunction or serum aspartate aminotransferase (AST) ; * 50 U/L, serum alanine transaminase (ATL) ; * 50 U/L, or serum bilirubin ; * 23 µmol/L. Hepatic clearance of the drug has not been studied.
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Conditions
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