Amebiasis Clinical Trial
Official title:
Field Studies of Human Immunity to Amebiasis in Bangladesh: A Prospective Study of Children Ages 0-17 Years
Verified date | April 2016 |
Source | University of Virginia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study will be to investigate the incidence of both Amebiasis and cryptosporidiosis in Bangladeshi children and examine genetic variation in innate and adaptive immunity with respect to these infections. Novel diagnostics to these infections will also be investigated.
Status | Completed |
Enrollment | 629 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 7 Days |
Eligibility |
Inclusion Criteria: - Resident of Mirpur, Dhaka, Bangladesh Exclusion Criteria: - Mother under 65 years old |
Country | Name | City | State |
---|---|---|---|
Bangladesh | The International Centre for Diarrhoeal Disease Research, Bangladesh | Dhaka |
Lead Sponsor | Collaborator |
---|---|
University of Virginia | International Centre for Diarrhoeal Disease Research, Bangladesh |
Bangladesh,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Amebiasis and Cryptosporidium infection | Birth to 5 years | ||
Secondary | Peripheral blood mononuclear cell Interleukin (IL)-1ß stimulation studies | Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease. | Birth to 5 years | |
Secondary | Peripheral blood mononuclear cell IL-2 stimulation studies | Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease. | Birth to 5 years | |
Secondary | Peripheral blood mononuclear cell IL-4 stimulation studies | Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease. | Birth to 5 years | |
Secondary | Peripheral blood mononuclear cell IL-5 stimulation studies | Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease. | Birth to 5 years | |
Secondary | Peripheral blood mononuclear cell IL-6 stimulation studies | Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease. | Birth to 5 years | |
Secondary | Peripheral blood mononuclear cell IL-7 stimulation studies | Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease. | Birth to 5 years | |
Secondary | Peripheral blood mononuclear cell IL-8 stimulation studies | Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease. | Birth to 5 years | |
Secondary | Peripheral blood mononuclear cell IL-10 stimulation studies | Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease. | Birth to 5 years | |
Secondary | Peripheral blood mononuclear cell IL-12(p70) stimulation studies | Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease. | Birth to 5 years | |
Secondary | Peripheral blood mononuclear cell IL-12(p40) stimulation studies | Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease. | Birth to 5 years | |
Secondary | Peripheral blood mononuclear cell IL-13 stimulation studies | Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease. | Birth to 5 years | |
Secondary | Peripheral blood mononuclear cell IL-17 stimulation studies | Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease. | Birth to 5 years | |
Secondary | Peripheral blood mononuclear cell interferon-? stimulation studies | Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease. | Birth to 5 years | |
Secondary | Peripheral blood mononuclear cell granulocyte-macrophage colony-stimulating factor stimulation studies | Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease. | Birth to 5 years | |
Secondary | Peripheral blood mononuclear cell tumor necrosis factor-a stimulation studies | Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease. | Birth to 5 years | |
Secondary | Peripheral blood mononuclear cell tumor necrosis factor-ß stimulation studies | Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease. | Birth to 5 years | |
Secondary | Peripheral blood mononuclear cell granulocyte-colony stimulating factor stimulation studies | Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease. | Birth to 5 years | |
Secondary | Peripheral blood mononuclear cell macrophage inflammatory protein (MIP)-1 ß stimulation studies | Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease. | Birth to 5 years | |
Secondary | Peripheral blood mononuclear cell MIP-1 a stimulation studies | Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease. | Birth to 5 years | |
Secondary | Peripheral blood mononuclear cell monocyte chemotactic protein-1 stimulation studies | Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease. | Birth to 5 years | |
Secondary | Peripheral blood mononuclear cell eotaxin stimulation studies | Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease. | Birth to 5 years | |
Secondary | Peripheral blood mononuclear cell fibroblast growth factor basic stimulation studies | Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease. | Birth to 5 years | |
Secondary | Peripheral blood mononuclear cell vascular endothelial growth factor stimulation studies | Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease. | Birth to 5 years | |
Secondary | Peripheral blood mononuclear cell "regulated on activation, normal T expressed and secreted" (RANTES) stimulation studies | Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease. | Birth to 5 years | |
Secondary | Peripheral blood mononuclear cell leptin stimulation studies | Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease. | Birth to 5 years | |
Secondary | Peripheral blood mononuclear cell epithelial neutrophil activating peptide (ENA)-78 stimulation studies | Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease. | Birth to 5 years | |
Secondary | Peripheral blood mononuclear cell nerve growth factor stimulation studies | Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease. | Birth to 5 years | |
Secondary | Peripheral blood mononuclear cell inducible protein-10 stimulation studies | Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease. | Birth to 5 years | |
Secondary | Fecal immunoglobulin-A | This will be collected as paired samples. One sample will be from each episode of Amebiasis diarrhea and will paired with a stool from that child when they have no Amebiasis detected in the stool and are without acute diarrhea. | Birth to 5 years | |
Secondary | Fecal immunoglobulin-G anti-cross-reacting determinant | This will be collected as paired samples. One sample will be from each episode of Amebiasis diarrhea and will paired with a stool from that child when they have no Amebiasis detected in the stool and are without acute diarrhea. | Birth to 5 years | |
Secondary | Single nucleotide polymorphism analysis of innate and adaptive immunity | Once; between birth and day 7 of life. | ||
Secondary | Genome wide association scan | Once, at 5 years of age | ||
Secondary | Fecal microbiome determination via 16s ribosomal deoxyribonucleic acid (rDNA) | Birth to 5 years | ||
Secondary | Length/Height in centimeters | Birth to 5 years | ||
Secondary | Weight in grams | Birth to 5 years |
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