Cryptosporidiosis and Enteropathogens in Bangladesh

University of Virginia

Status: Active, not recruiting

Conditions: Cryptosporidiosis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02764918

R01AI043596 (U.S. NIH Grant/Contract)

PR13092

Details and patient eligibility

About

The purpose of this study is to explore the role of anti-parasite antibody in protection of children from the parasitic infection cryptosporidiosis. This work has the promise of identifying immune pathways important for protection from parasitic infections of the gut, and will help with designing a vaccine to prevent this infection estimated to cause, from diarrhea and malnutrition, an overall burden of 12 million disability-adjusted life-years in children.

Enrollment: 150 estimated patients

Sex: All

Ages: 1 to 7 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Mother willing to sign informed consent form.
• Healthy infant
• No obvious congenital abnormalities or birth defects.
• Stable household with no plans to leave the area for the next one year.

Exclusion criteria

• Parents are not willing to have child's blood drawn.
• Parents are planning to enroll child into another interventional clinical study during the time period of this trial that could affect the outcomes of this study.
• Mother not willing to have blood drawn and breast milk extracted.
• Parents not willing to have field research assistant in home two times per week.
• History of seizures or other apparent neurologic disorders.
• Infant has any sibling currently or previously enrolled in this study, including a twin.

Trial design

150 participants in 2 patient groups

Children

Description:

n=150

Mothers

Description:

n=150