What is this study trying to find out about cryptosporidiosis in children?

This study aims to understand how cryptosporidiosis, a diarrheal infection caused by Cryptosporidium, appears and progresses in children aged 6 to 59 months. Researchers want to learn about the symptoms, severity, and duration of diarrhea in affected kids. The study is sponsored by Novartis Pharmaceuticals and helps improve knowledge about this infection in young children.

Who may be eligible for this cryptosporidiosis clinical trial?

Children between 6 months and 59 months old with diarrhea caused by Cryptosporidium infection may be eligible. The study includes those with acute to chronic diarrhea and various nutritional statuses. Children with visible blood in stool or severe infections requiring intensive care are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this cryptosporidiosis clinical trial?

Study-related care, including all assessments and follow-up, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants and their families should plan accordingly.

Actively Recruiting

Age: 6Months - 59Months

All Genders

ID07716410

Study of Cryptosporidium Infection and Diarrhea in Children Aged 6 to 59 Months to Understand Clinical Presentation and Disease Course

Led by Novartis Pharmaceuticals · Updated on 2026-07-21

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying pediatric cryptosporidiosis to better understand how this infection presents and progresses in children aged 6 to 59 months. The focus is on characterizing the clinical features and course of diarrhea caused by Cryptosporidium, a parasite common in certain regions. This observational study aims to gather detailed information on symptoms and outcomes in affected children. Participants are children with diarrhea due to Cryptosporidium infection confirmed by specific stool tests. The study observes children with varying durations of diarrheafrom acute to chronicand different nutritional statuses. The study follows children for up to 21 days, monitoring diarrhea severity, dehydration, and parasite presence without administering any treatment. During participation, children will be assessed at multiple time points including baseline, days 3, 7, 14, and up to day 21. Researchers will collect stool samples and evaluate dehydration severity, diarrhea resolution time, and parasite shedding. Additional factors like age, nutritional status, and breastfeeding history will be analyzed to understand their association with illness duration and severity. Participants will be followed closely to capture the natural course of infection and symptoms.

CONDITIONS

Brief Title

A Study to Characterize the Clinical Presentation and Course of Cryptosporidium in Pediatric Participants

Who Can Participate

Age: 6Months - 59Months

All Genders

Eligibility Criteria

You may qualify if you...

Age 6 months to 59 months with diarrhea defined as 3 or more loose stools daily for at least 2 days
Positive stool tests for Cryptosporidium by QuikChek™ and microscopy at screening
Diarrhea duration classified as acute (<7 days), prolonged (7-13 days), persistent (14-28 days), or chronic (>28 days) at screening
Nutritional status normal, mildly-to-moderately malnourished, or severely acutely malnourished (with a cap on severe cases) at screening
Parent or primary caregiver willing to provide consent and comply with study procedures including stool sample collection and follow-up up to 21 days

You will not qualify if you...

Presence of bloody diarrhea with visible blood in stool
Other illnesses requiring emergency care in an intensive care setting at screening
Concurrent non-enteric infections such as upper or lower respiratory infections at screening
Parent or caregiver unwilling or unable to cooperate with study procedures
Caregiver has travel plans that would prevent clinic or home visits during study follow-up

Research Team

Novartis Pharmaceuticals

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here