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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT02734264
Date of registration:	22/03/2016
Prospective Registration:	No
Primary sponsor:	University of Virginia
Public title:	Field Studies of Amebiasis in Bangladesh
Scientific title:	Field Studies of Human Immunity to Amebiasis in Bangladesh: A Prospective Study of Children Ages 0-17 Years
Date of first enrolment:	January 2008
Target sample size:	629
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02734264
Study type:	Observational
Study design:
Phase:	N/A

Countries of recruitment
Bangladesh

Contacts

Name:	William A Petri, M.D., PhD
Address:
Telephone:
Email:
Affiliation:	University of Virginia

Key inclusion & exclusion criteria

Inclusion Criteria:

- Resident of Mirpur, Dhaka, Bangladesh

Exclusion Criteria:

- Mother under 65 years old

Age minimum: N/A
Age maximum: 7 Days
Gender: All

Health Condition(s) or Problem(s) studied

Amebiasis

Cryptosporidium

Intervention(s)

Primary Outcome(s)

Incidence of Amebiasis and Cryptosporidium infection [Time Frame: Birth to 5 years]

Secondary Outcome(s)

Peripheral blood mononuclear cell IL-2 stimulation studies [Time Frame: Birth to 5 years]

Fecal immunoglobulin-A [Time Frame: Birth to 5 years]

Peripheral blood mononuclear cell fibroblast growth factor basic stimulation studies [Time Frame: Birth to 5 years]

Peripheral blood mononuclear cell IL-10 stimulation studies [Time Frame: Birth to 5 years]

Peripheral blood mononuclear cell IL-12(p70) stimulation studies [Time Frame: Birth to 5 years]

Peripheral blood mononuclear cell tumor necrosis factor-ß stimulation studies [Time Frame: Birth to 5 years]

Fecal immunoglobulin-G anti-cross-reacting determinant [Time Frame: Birth to 5 years]

Length/Height in centimeters [Time Frame: Birth to 5 years]

Peripheral blood mononuclear cell "regulated on activation, normal T expressed and secreted" (RANTES) stimulation studies [Time Frame: Birth to 5 years]

Fecal microbiome determination via 16s ribosomal deoxyribonucleic acid (rDNA) [Time Frame: Birth to 5 years]

Peripheral blood mononuclear cell inducible protein-10 stimulation studies [Time Frame: Birth to 5 years]

Peripheral blood mononuclear cell interferon-? stimulation studies [Time Frame: Birth to 5 years]

Peripheral blood mononuclear cell tumor necrosis factor-a stimulation studies [Time Frame: Birth to 5 years]

Peripheral blood mononuclear cell epithelial neutrophil activating peptide (ENA)-78 stimulation studies [Time Frame: Birth to 5 years]

Peripheral blood mononuclear cell IL-8 stimulation studies [Time Frame: Birth to 5 years]

Peripheral blood mononuclear cell vascular endothelial growth factor stimulation studies [Time Frame: Birth to 5 years]

Genome wide association scan [Time Frame: Once, at 5 years of age]

Peripheral blood mononuclear cell eotaxin stimulation studies [Time Frame: Birth to 5 years]

Peripheral blood mononuclear cell granulocyte-colony stimulating factor stimulation studies [Time Frame: Birth to 5 years]

Single nucleotide polymorphism analysis of innate and adaptive immunity [Time Frame: Once; between birth and day 7 of life.]

Peripheral blood mononuclear cell IL-13 stimulation studies [Time Frame: Birth to 5 years]

Peripheral blood mononuclear cell IL-17 stimulation studies [Time Frame: Birth to 5 years]

Peripheral blood mononuclear cell granulocyte-macrophage colony-stimulating factor stimulation studies [Time Frame: Birth to 5 years]

Peripheral blood mononuclear cell IL-12(p40) stimulation studies [Time Frame: Birth to 5 years]

Peripheral blood mononuclear cell IL-4 stimulation studies [Time Frame: Birth to 5 years]

Peripheral blood mononuclear cell IL-7 stimulation studies [Time Frame: Birth to 5 years]

Peripheral blood mononuclear cell Interleukin (IL)-1ß stimulation studies [Time Frame: Birth to 5 years]

Peripheral blood mononuclear cell IL-5 stimulation studies [Time Frame: Birth to 5 years]

Peripheral blood mononuclear cell IL-6 stimulation studies [Time Frame: Birth to 5 years]

Peripheral blood mononuclear cell macrophage inflammatory protein (MIP)-1 ß stimulation studies [Time Frame: Birth to 5 years]

Peripheral blood mononuclear cell leptin stimulation studies [Time Frame: Birth to 5 years]

Peripheral blood mononuclear cell MIP-1 a stimulation studies [Time Frame: Birth to 5 years]

Peripheral blood mononuclear cell monocyte chemotactic protein-1 stimulation studies [Time Frame: Birth to 5 years]

Peripheral blood mononuclear cell nerve growth factor stimulation studies [Time Frame: Birth to 5 years]

Weight in grams [Time Frame: Birth to 5 years]

Secondary ID(s)

7563

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

International Centre for Diarrhoeal Disease Research, Bangladesh

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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