Cryptosporidiosis and Enteropathogens in Bangladesh

Cryptosporidiosis Clinical Trial

Official title:

Field Studies of Cryptosporidiosis and Enteropathogens in Bangladesh

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02764918
• Other study ID #: PR13092
• Status: Active, not recruiting
• Start date: June 15, 2014
• Est. completion date: March 2025

Study information

• Verified date: August 2023
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to investigate the incidence of Cryptosporidiosis in Bangladeshi children and describe the acquired immune response to the pathogen as well investigate the potential of human genetic susceptibility.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: March 2025
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 7 Days

Eligibility

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.

Related Conditions & MeSH terms

• Cryptosporidiosis

Locations

Country	Name	City	State
Bangladesh	The International Centre for Diarrhoeal Disease Research, Bangladesh	Dhaka

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	International Centre for Diarrhoeal Disease Research, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

Gilchrist CA, Campo JJ, Pablo JV, Ma JZ, Teng A, Oberai A, Shandling AD, Alam M, Kabir M, Faruque AS, Haque R, Petri WA Jr. Specific Cryptosporidium antigens associate with reinfection immunity and protection from cryptosporidiosis. J Clin Invest. 2023 Jun 22:e166814. doi: 10.1172/JCI166814. Online ahead of print. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Cryptosporidiosis	To be completed on children	Birth to 4 years old
Secondary	Fecal Myeloperoxidase (MPO)	To be conducted on mothers	Once, during the 3rd trimester of pregnancy
Secondary	Fecal Regenerating Islet-Derived 1 Beta (Reg 1B)	To be conducted on mothers	Once, during the 3rd trimester of pregnancy
Secondary	Fetal biophysical profile via ultrasound	To be conducted on mothers	Once, at the start of the 3rd trimester of pregnancy
Secondary	Breast milk immunoglobulin A (IgA)	To be conducted on mothers	From child's birth to 4 months postpartum
Secondary	Socioeconomic status questionnaire	To be conducted on mothers	At enrollment
Secondary	Household sanitation questionnaire	To be conducted on mothers	At enrollment
Secondary	Fecal Myeloperoxidase (MPO)	To be conducted on children	Birth to 4 years old
Secondary	Fecal Regenerating Islet-Derived 1 Beta (Reg 1B)	To be conducted on children	Birth to 4 years old
Secondary	Serum soluble cluster of differentiation 14 (sCD14)	To be conducted on children	Birth to 4 years old
Secondary	Serum interleukin 14 (IL 14)	To be conducted on children	Birth to 4 years old
Secondary	Serum interleukin 1B (IL 1B)	To be conducted on children	Birth to 4 years old
Secondary	Assessment of 1300 known single nucleotide polymorphisms	To be conducted on children	once: at 4 years old
Secondary	Polymerase chain reaction (PCR) for common diarrheal pathogens	To be conducted on children's diarrheal stool	Birth to 4 years old
Secondary	Episodes of wheeze	To be conducted on children	Birth to 4 years old
Secondary	Episodes of acute respiratory infection	To be conducted on children	Birth to 4 years old