Cryptosporidiosis and Enteropathogens in Bangladesh

Study Overview
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Brief Summary
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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.

Official Title
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Field Studies of Cryptosporidiosis and Enteropathogens in Bangladesh

Conditions
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Cryptosporidiosis

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 7 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children<br> | |
| Mothers<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Cryptosporidiosis | To be completed on children | Birth to 4 years old | 

Secondary Outcome Measures

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