Cryptosporidiosis and Enteropathogens in Bangladesh

N/AActive Not RecruitingNCT02764918

University of Virginia150 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Cryptosporidiosis

Eligibility

Sex: ALLMin age: 1 DayMax age: 7 DaysHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

The International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, Bangladesh

Outcomes

Primary Outcomes

Functional characterization of anti-Cryptosporidium antibodies associated with protection

Measure antibody isotype and subclass, mucosal (stool) vs systemic (plasma), complement fixation and opsonophagocytosis using bead-based multiplex immunoassays.

Time frame: Birth until 4 years

Secondary Outcomes

In depth characterization of Cryptosporidium antigens recognized by the child humoral immune response

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.

Time frame: Birth until 4 years.

Polymerase chain reaction (PCR) testing for diarrheal pathogens during acute infection

To be conducted on children's acute and convalescent stool during diarrheal episodes.

Time frame: Birth to 4 years old

Determine the role of circulating T follicular helper (cTfh) cells in induction of antibody response

Use Activation Induced Marker (AIM) assays to test parasite infection-dependent changes in the activation, frequency, and immunophenotype of circulating Tfh cells.

Time frame: Through collection of blood specimens on day 0, 14 and 28 during acute infection.

Determination of maternal humoral response and impact on child infection/immunity

Collect mother blood, stool and breast milk on enrollment. Collect second breast milk at 4 months.

Time frame: On enrollment (all) and 4 months (breast milk only).

Surveillance polymerase chain reaction (PCR) testing for diarrheal pathogens

To be conducted on child non diarrheal stool collected twice monthly.

Data from ClinicalTrials.gov

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