Field studies of Cryptosporidiosis and Enteropathogens in Bangladesh

Cryptosporidiosis causes severe diarrhea in infants in the developing world. There is no vaccine to prevent it, and little in the way of treatment. This study on Bangladeshi urban slum children aims to support the design of a vaccine, both by determining how the immune system protects from infection and by identifying the genotypes of the parasite that should be included in a vaccine, as well as aid in development of therapies by identifying human genes that control infection. The primary objective of the study was to determine the incidence and contribution to disease of the different species and genotypes of cryptosporidia. Secondary objectives were designed to determine acquired immune response to cryptosporidiosis and identify human genes that influence susceptibility to cryptosporidiosis. This is an observational study. Children were recruited from Mirpur Dhaka slum (Cohort 1) and rural Mirzapur (Cohort 2) and followed for cryptosporidium infection longitudinally from birth through age 4 years in Cohort 1 and birth through age 2 years in Cohort 2. Biweekly household visits for diarrheal surveillance were made in addition to anthropometric measurements of mother and child, blood samples collected two times each year from the child, a work-up of diarrheal stools and non-diarrheal surveillance stools for cryptosporidium and other enteropathogens, and blood and breast milk samples from the mother. A detailed description of the study design and procedures can be obtained from publication: Kevin L Steiner, et al., 2018, PMID: 29897482.]]>
Inclusion Criteria All of the following criteria were met for a subject to be eligible to participate in the study: Mother having healthy pregnancy and willing to sign informed consent form Cohort #1: Healthy infant aged 0 to 7 days old, or less than 5 years of age and currently enrolled in DMID protocol 07-0054 No obvious congenital abnormalities or birth defects Cohort # 2: No abnormal (frequency and consistency) stools since birth Stable household with no plans to leave the area for the next two years Exclusion Criteria Meeting any of the following criteria at baseline were excluded from study participation: Parents not willing to have child's blood drawn or not willing to provide child's stool samples Parents 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, or provide urine and stool sample Parents not willing to have field research assistant in home twice per week History of seizures or other apparent neurologic disorders Any sibling, including a twin, currently or previously enrolled in this study. ]]>
Enrollment of 500 infants in Cohort 1 occurred between June 2014 and March 2016, and 258 infants in Cohort 2 were enrolled between June 2014 and March 2015. The infants were followed by twice-weekly household visits and scheduled clinic visits over the first 4 and 2 years of life, respectively.]]>