Clinical Trial: Cryptosporidiosis and Enteropathogens in Bangladesh

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Field Studies of Cryptosporidiosis and Enteropathogens in Bangladesh

Brief 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.

Detailed Summary:
Sponsor: University of Virginia

Current Primary Outcome: Incidence of Cryptosporidiosis [ Time Frame: Birth to 4 years old ]

To be completed on children


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: University of Virginia

Dates:
Date Received: May 2, 2016
Date Started: January 2014
Date Completion: January 2018
Last Updated: May 4, 2016
Last Verified: May 2016