Cryptosporidiosis and Enteropathogens in Bangladesh

Active, not recruiting

• Conditions: Cryptosporidiosis

• Registration Number: NCT02764918
• Lead Sponsor: University of Virginia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-02
• Study First Submitted QC: 2016-05-04
• Study First Posted: 2016-05-06
• Study Start: 2024-10-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2028-10
• Study Completion: 2029-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional characterization of anti-Cryptosporidium antibodies associated with protection	Birth until 4 years	Measure antibody isotype and subclass, mucosal (stool) vs systemic (plasma), complement fixation and opsonophagocytosis using bead-based multiplex immunoassays.

Secondary Outcome Measures

Name	Time	Method
In depth characterization of Cryptosporidium antigens recognized by the child humoral immune response	Birth until 4 years.	Utilize this longitudinal study of children and a Cryptosporidium protein microarray to probe plasma for the breadth of antigens recognized as well as the specific antigens to which children respond as they develop protective immunity.
Polymerase chain reaction (PCR) testing for diarrheal pathogens during acute infection	Birth to 4 years old	To be conducted on children's acute and convalescent stool during diarrheal episodes.
Determine the role of circulating T follicular helper (cTfh) cells in induction of antibody response	Through collection of blood specimens on day 0, 14 and 28 during acute infection.	Use Activation Induced Marker (AIM) assays to test parasite infection-dependent changes in the activation, frequency, and immunophenotype of circulating Tfh cells.
Determination of maternal humoral response and impact on child infection/immunity	On enrollment (all) and 4 months (breast milk only).	Collect mother blood, stool and breast milk on enrollment. Collect second breast milk at 4 months.
Surveillance polymerase chain reaction (PCR) testing for diarrheal pathogens	Birth until 4 years.	To be conducted on child non diarrheal stool collected twice monthly.
Determine child anthropometric measures	Every 6 months until 4 years	Collect height, weight, mid-upper arm circumference.
Socioeconomic status questionnaire	At enrollment	To be conducted on mothers.
Household sanitation questionnaire	At enrollment	To be conducted on mothers.

Trial Locations

Locations (1)

The International Centre for Diarrhoeal Disease Research, Bangladesh; 🇧🇩 Dhaka, Bangladesh