Cryptosporidiosis and Enteropathogens in Bangladesh

Active, not recruiting

• Conditions: Cryptosporidiosis

• Registration Number: NCT02764918
• Lead Sponsor: University of Virginia

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 Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-06-15
• Study First Submitted: 2016-05-02
• Study First Submitted QC: 2016-05-04
• Study First Posted: 2016-05-06
• Primary Completion: 2018-08
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-22
• Last Update Posted: 2023-08-24
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 500

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Cryptosporidiosis	Birth to 4 years old	To be completed on children

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The International Centre for Diarrhoeal Disease Research, Bangladesh; 🇧🇩 Dhaka, Bangladesh