Cryptosporidiosis and Enteropathogens in Bangladesh

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-01

Study Completion Date

2029-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cryptosporidiosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Children

n=150

No interventions assigned to this group

Mothers

n=150

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

1 Day

Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes