New study aims to decode a hidden threat to Children's health

NCT ID NCT07716410

Knowledge-focused Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This study looks at how cryptosporidiosis, a diarrheal disease, affects children aged 6 months to 5 years in countries where it is common. Researchers will track how long diarrhea lasts and how dehydrated children become. The goal is to better understand the disease to guide future treatments and prevention.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to: If successful, this study could help design better treatments and vaccines for cryptosporidiosis in children.
What could go wrong: This is an observational study with only 30 children, so findings may not apply broadly. It does not test any treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Pediatric participants presenting with diarrhea and testing positive for Cryptosporidium by QuikChek™ and microscopy.

Ages

6 to 59 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * Age 6 months to 59 months with diarrhea according to the World Health Organization (WHO) criteria (≥3 loose stools daily for at least 2 days) * QuikChek™ and Stool microscopy positive for Cryptosporidium at screening * Acute (\<7 days), prolonged (lasting 7-13 days), persistent (lasting 14-28 days) or chronic (lasting \>28 days) diarrheal illness (≥3 loose stools daily, as defined by WHO) at screening * Normal nutritional status, mildly-to-moderately acutely malnourished, or severely acutely malnourished according to WHO definitions (number of participants with severe acute malnutrition will be capped) at screening * Parent or primary caregiver is willing to provide informed consent and to comply with study procedures, including provision of whole stool samples at the scheduled time points and willing to be followed up to 21 days Exclusion criteria: * Bloody diarrhea, defined as diarrhea with visible blood in stool as observed by the study team member performing the screening or reported by parent/primary caregiver * Other morbidity requiring emergency medical care in an intensive care setting at the time of screening * Coincident non-enteric infection including upper or lower respiratory infection at screening * Any participant whose parent or primary caregiver is unwilling or unable to cooperate with study procedures, in the investigator's opinion * If the parent/primary caregiver managing care of the patient has travel plans out of the study area that would preclude clinic or in-home study visits during the expected study follow-up period Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

cryptosporidiosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cryptosporidiosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

4 sites in 3 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

New study aims to decode a hidden threat to Children's health

What the study statuses mean