Actively Recruiting

Age: 2Years - 120Years
All Genders
ID06479837

Modeling Host-Pathogen Interaction Using Lymphoid Organoids

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-06-08

500

Participants Needed

2

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how Staphylococcus aureus bacteria interact with human cells, focusing on infections in the spine that can cause serious complications. This observational study collects tonsil tissues discarded after routine tonsil removal surgery to develop lymphoid organoid models. The goal is to better understand human immune responses, especially the body's reaction to a bacterial protein called CHIPS, which may influence infection outcomes. Participants are patients scheduled for tonsillectomy as part of their clinical care. Before surgery, participants will collect a nasal swab using a provided tool. After surgery, surgeons will save tonsil tissue samples, which researchers will use to study immune cell composition, antibody levels, cytokines, and specific immune mechanisms related to CHIPS exposure. The study also explores how immune responses change with repeated bacterial exposure. Participants will provide health information through questionnaires online or on paper. Researchers will review medical records, imaging, and blood tests to select participants. The main measurements include immune cell makeup, antibody types and activity, cytokine levels, and genetic markers of immune activation. Samples and data may be stored for future studies, and genetic testing might be performed on collected biospecimens. The study runs until December 2044 and includes participants aged 2 years and older undergoing tonsillectomy.

CONDITIONS

Brief Title

Modeling Host-Pathogen Interaction Using Lymphoid Organoids

Who Can Participate

Age: 2Years - 120Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 62 years
  • Undergoing tonsillectomy as part of their clinical care
  • Able to provide informed consent (for ages 6518 years) or has a parent or guardian who can provide informed consent on their behalf (for ages 6418 yrs)
  • Willing to allow samples and data to be stored and shared for future secondary research
  • Willing to allow future genetic testing on their biospecimens
Not Eligible

You will not qualify if you...

  • Active infection
  • Active tonsilitis
  • Pregnant
  • Diagnosed with an immunosuppressive condition or currently taking immunosuppressive medications
  • Current or past intravenous drug use
  • Any condition that may put the participant at undue risk or make them unsuitable for participation in the study

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) prior to tonsillectomy

Sample Collection

Duration - Day of tonsillectomy

Participants undergoing tonsillectomy as part of their routine clinical care provide tonsil tissues that are collected for research purposes.

1 visit during tonsillectomy procedure

Sample Analysis and Monitoring

Duration - Ongoing during study period

Collected tonsil tissues are used to develop lymphoid organoid models to evaluate host-pathogen interactions in human health and disease.

No additional visits required for participants

Trial Site Locations

Total: 2 locations

1

National Institute of Allergy and Infectious Diseases (NIAID)

Bethesda, Maryland, United States, 20892

Actively Recruiting

2

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

K

Katherine Le, M.D.

M

Michael Otto, M.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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