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AzTrials

CryptosporidiosisNCT02764918

Cryptosporidiosis and Enteropathogens in Bangladesh

An observational study of Cryptosporidiosis, run by University of Virginia at 1 site in Bangladesh.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 1 day to 7 daysHealthy volunteers can take part
Conditions the study is for
Cryptosporidiosis
How many people
150 participants
Where
1 siteBangladesh
Study dates
1 Oct 2024to Oct 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 7 days
  • All sexes
  • Healthy volunteers accepted
  • Child

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site

  • The International Centre for Diarrhoeal Disease Research, Bangladesh

    Dhaka

Other trials in Bangladesh

About this study

Official title: 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.

Medical subject headings
Cryptosporidiosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02764918
Study groupRoleWhat they receive
Childrenn=150
Mothersn=150

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Birth until 4 years

Secondary outcomes (8)

  1. 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.

    Measured: Birth until 4 years.

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

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

    Measured: Birth to 4 years old

  3. 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.

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

  4. 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.

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

  5. Surveillance polymerase chain reaction (PCR) testing for diarrheal pathogens

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

    Measured: Birth until 4 years.

  6. Determine child anthropometric measures

    Collect height, weight, mid-upper arm circumference.

    Measured: Every 6 months until 4 years

  7. Socioeconomic status questionnaire

    To be conducted on mothers.

    Measured: At enrollment

  8. Household sanitation questionnaire

    To be conducted on mothers.

    Measured: At enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2016 (estimated)
  2. Study start1 Oct 2024
  3. Primary completionOct 2028 (estimated)
  4. Study completionOct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02764918
Sponsor's protocol ID
PR13092
Other IDs
R01AI043596
Status last verified
Mar 2025
First submitted
2 May 2016
Last updated
30 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gilchrist CA, Cotton JA, Burkey C, Arju T, Gilmartin A, Lin Y, Ahmed E, Steiner K, Alam M, Ahmed S, Robinson G, Zaman SU, Kabir M, Sanders M, Chalmers RM, Ahmed T, Ma JZ, Haque R, Faruque ASG, Berriman M, Petri WA. Genetic Diversity of Cryptosporidium hominis in a Bangladeshi Community as Revealed by Whole-Genome Sequencing. J Infect Dis. 2018 Jun 20;218(2):259-264. doi: 10.1093/infdis/jiy121.

    PubMed 29514308

  • Steiner KL, Ahmed S, Gilchrist CA, Burkey C, Cook H, Ma JZ, Korpe PS, Ahmed E, Alam M, Kabir M, Tofail F, Ahmed T, Haque R, Petri WA Jr, Faruque ASG. Species of Cryptosporidia Causing Subclinical Infection Associated With Growth Faltering in Rural and Urban Bangladesh: A Birth Cohort Study. Clin Infect Dis. 2018 Oct 15;67(9):1347-1355. doi: 10.1093/cid/ciy310.

    PubMed 29897482

  • Steiner KL, Kabir M, Priest JW, Hossain B, Gilchrist CA, Cook H, Ma JZ, Korpe PS, Ahmed T, Faruque ASG, Haque R, Petri WA. Fecal Immunoglobulin A Against a Sporozoite Antigen at 12 Months Is Associated With Delayed Time to Subsequent Cryptosporidiosis in Urban Bangladesh: A Prospective Cohort Study. Clin Infect Dis. 2020 Jan 2;70(2):323-326. doi: 10.1093/cid/ciz430.

    PubMed 31131855

  • Donowitz JR, Drew J, Taniuchi M, Platts-Mills JA, Alam M, Ferdous T, Shama T, Islam MO, Kabir M, Nayak U, Haque R, Petri WA. Diarrheal Pathogens Associated With Growth and Neurodevelopment. Clin Infect Dis. 2021 Aug 2;73(3):e683-e691. doi: 10.1093/cid/ciaa1938.

    PubMed 33399861

  • Donowitz JR, Pu Z, Lin Y, Alam M, Ferdous T, Shama T, Taniuchi M, Islam MO, Kabir M, Nayak U, Faruque ASG, Haque R, Ma JZ, Petri WA Jr. Small Intestine Bacterial Overgrowth in Bangladeshi Infants Is Associated With Growth Stunting in a Longitudinal Cohort. Am J Gastroenterol. 2022 Jan 1;117(1):167-175. doi: 10.14309/ajg.0000000000001535.

    PubMed 34693912

  • Kabir M, Alam M, Nayak U, Arju T, Hossain B, Tarannum R, Khatun A, White JA, Ma JZ, Haque R, Petri WA Jr, Gilchrist CA. Nonsterile immunity to cryptosporidiosis in infants is associated with mucosal IgA against the sporozoite and protection from malnutrition. PLoS Pathog. 2021 Jun 28;17(6):e1009445. doi: 10.1371/journal.ppat.1009445. eCollection 2021 Jun.

    PubMed 34181697

  • Carey MA, Medlock GL, Alam M, Kabir M, Uddin MJ, Nayak U, Papin J, Faruque ASG, Haque R, Petri WA, Gilchrist CA. Megasphaera in the Stool Microbiota Is Negatively Associated With Diarrheal Cryptosporidiosis. Clin Infect Dis. 2021 Sep 15;73(6):e1242-e1251. doi: 10.1093/cid/ciab207.

    PubMed 33684930

  • Gilchrist CA, Campo JJ, Pablo JV, Ma JZ, Teng A, Oberai A, Shandling AD, Alam M, Kabir M, Faruque ASG, Haque R, Petri WA Jr. Specific Cryptosporidium antigens associate with reinfection immunity and protection from cryptosporidiosis. J Clin Invest. 2023 Aug 15;133(16):e166814. doi: 10.1172/JCI166814.

    PubMed 37347553

  • Gilchrist CA, Petri WAO, Hossain B, Kabir M, So HH, Moreau GB, Nayak U, Ma JZ, Noor Z, Faruque ASG, Alam M, Haque R, Petri WA Jr. Decrease in Incidence of Diarrhea Due to Cryptosporidium in Bangladeshi Children Is Associated With an Increase in Anti-Cryptosporidium Antibody Avidity. J Infect Dis. 2025 Sep 15;232(3):e362-e371. doi: 10.1093/infdis/jiaf253.

    PubMed 40488529

  • Carey M, Arju T, Cotton JA, Alam M, Kabir M, Faruque ASG, Haque R, Petri WA Jr, Gilchrist CA. Genomic Heterogeneity of Cryptosporidium parvum Isolates From Children in Bangladesh: Implications for Parasite Biology and Human Infection. J Infect Dis. 2023 Nov 2;228(9):1292-1298. doi: 10.1093/infdis/jiad257.

    PubMed 37832036

Questions about this trial

What is this clinical trial studying?

An observational study of Cryptosporidiosis, run by University of Virginia at 1 site in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional characterization of anti-Cryptosporidium antibodies associated with protection (time frame: Birth until 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02764918, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.

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