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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Children
n=150
Mothers
n=150

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Virginia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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