Cryptosporidiosis and Enteropathogens in Bangladesh

March 25, 2025 updated by: William Petri, MD, PhD, University of Virginia

Field Studies of Cryptosporidiosis and Enteropathogens in Bangladesh

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 Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh
        • The International Centre for Diarrhoeal Disease Research, Bangladesh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 week (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Mother-child pairs from the Mirpur Neighborhood of Dhaka, Bangladesh

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Children
n=150
Mothers
n=150

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In depth characterization of Cryptosporidium antigens recognized by the child humoral immune response
Time Frame: 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.
Birth until 4 years.
Polymerase chain reaction (PCR) testing for diarrheal pathogens during acute infection
Time Frame: Birth to 4 years old
To be conducted on children's acute and convalescent stool during diarrheal episodes.
Birth to 4 years old
Determine the role of circulating T follicular helper (cTfh) cells in induction of antibody response
Time Frame: 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.
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
Time Frame: 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.
On enrollment (all) and 4 months (breast milk only).
Surveillance polymerase chain reaction (PCR) testing for diarrheal pathogens
Time Frame: Birth until 4 years.
To be conducted on child non diarrheal stool collected twice monthly.
Birth until 4 years.
Determine child anthropometric measures
Time Frame: Every 6 months until 4 years
Collect height, weight, mid-upper arm circumference.
Every 6 months until 4 years
Socioeconomic status questionnaire
Time Frame: At enrollment
To be conducted on mothers.
At enrollment
Household sanitation questionnaire
Time Frame: At enrollment
To be conducted on mothers.
At enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

National Institutes of Health (NIH)
International Centre for Diarrhoeal Disease Research, Bangladesh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2029

Study Registration Dates

First Submitted

May 2, 2016

First Submitted That Met QC Criteria

May 4, 2016

First Posted (Estimated)

May 6, 2016

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR13092
  • R01AI043596 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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