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NCT Number: NCT02764918

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cryptosporidiosis Animal Diseases Coccidiosis Digestive System Diseases Gastrointestinal Diseases Infections Intestinal Diseases Intestinal Diseases, Parasitic Parasitic Diseases Parasitic Diseases, Animal Protozoan Infections Protozoan Infections, Animal

Age range

1 day–7 day

Sex eligibility

All sexes

Study type

Observational

Primary location

The International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, Bangladesh

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Determine child anthropometric measures

    Time frame: Every 6 months until 4 years

    Collect height, weight, mid-upper arm circumference.

  7. Socioeconomic status questionnaire

    Time frame: At enrollment

    To be conducted on mothers.

  8. Household sanitation questionnaire

    Time frame: At enrollment

    To be conducted on mothers.

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

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

Registry information

Official study title

Field Studies of Cryptosporidiosis and Enteropathogens in Bangladesh

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
May 6, 2016
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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