NCT02734264

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
629

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed
Last Updated

October 26, 2017

Status Verified

April 1, 2016

Enrollment Period

6.9 years

First QC Date

March 22, 2016

Last Update Submit

October 24, 2017

Conditions

AmebiasisCryptosporidium

Outcome Measures

Primary Outcomes (1)

  • Incidence of Amebiasis and Cryptosporidium infection

    Birth to 5 years

Secondary Outcomes (35)

  • Peripheral blood mononuclear cell Interleukin (IL)-1β stimulation studies

    Birth to 5 years

  • Peripheral blood mononuclear cell IL-2 stimulation studies

    Birth to 5 years

  • Peripheral blood mononuclear cell IL-4 stimulation studies

    Birth to 5 years

  • Peripheral blood mononuclear cell IL-5 stimulation studies

    Birth to 5 years

  • Peripheral blood mononuclear cell IL-6 stimulation studies

    Birth to 5 years

  • +30 more secondary outcomes

Eligibility Criteria

AgeUp to 7 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Newborn children in the Mirpur neighborhood of Dhaka, Bangladesh.

You may qualify if:

  • Resident of Mirpur, Dhaka, Bangladesh

You may not qualify if:

  • Mother under 65 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, Bangladesh

Location

Related Publications (1)

  • Zhang Y, Zhou J, Niu F, Donowitz JR, Haque R, Petri WA Jr, Ma JZ. Characterizing early child growth patterns of height-for-age in an urban slum cohort of Bangladesh with functional principal component analysis. BMC Pediatr. 2017 Mar 21;17(1):84. doi: 10.1186/s12887-017-0831-y.

    PMID: 28327104DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum and feces

MeSH Terms

Conditions

Amebiasis

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfections

Study Officials

  • William A Petri, M.D., PhD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division Chief, Infectious Disease

Study Record Dates

First Submitted

March 22, 2016

First Posted

April 12, 2016

Study Start

January 1, 2008

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

October 26, 2017

Record last verified: 2016-04

Locations

BA(1)