Cryptosporidiosis and Enteropathogens in Bangladesh

NCT02764918 | Active Not Recruiting

• 2 other identifiers: PR13092R01AI043596
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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 this infection estimated to cause, from diarrhea and malnutrition, an overall burden of 12 million disability-adjusted life-years in children.

Conditions

Cryptosporidiosis

Outcome Measures

Primary Outcomes (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.

  Birth until 4 years

Secondary Outcomes (8)

• In depth characterization of Cryptosporidium antigens recognized by the child humoral immune response

  Birth until 4 years.

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

  Birth to 4 years old

• Determine the role of circulating T follicular helper (cTfh) cells in induction of antibody response

  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

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

• Surveillance polymerase chain reaction (PCR) testing for diarrheal pathogens

  Birth until 4 years.

Study Arms (2)

Children

n=150

Mothers

n=150

Eligibility Criteria

• Age: 1 Day - 7 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Virginia: lead
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

The International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, Bangladesh

Location

Related Publications (10)

• 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.

  PMID: 29514308 BACKGROUND

• 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.

  PMID: 29897482 BACKGROUND

• 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.

  PMID: 31131855 BACKGROUND

• 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.

  PMID: 33399861 BACKGROUND

• 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.

  PMID: 34693912 BACKGROUND

• 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.

  PMID: 34181697 BACKGROUND

• 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.

  PMID: 33684930 BACKGROUND

• 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.

  PMID: 37347553 BACKGROUND

• 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.

  PMID: 40488529 DERIVED

• 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.

  PMID: 37832036 DERIVED

MeSH Terms

Conditions

Cryptosporidiosis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chief, Infectious Disease

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 6, 2016
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)