Bacterial Microbiota In The Tonsils Of Children

April 24, 2023 updated by: University of Chicago

Bacterial Microbiota In The Tonsils Of Children Undergoing Adenotonsillectomy And Normal Controls

We, the investigators, propose to look at the bacteria on and in tonsils using gene microarrays. We expect to find previously reported bacteria but also the possibility of previously undetected organisms. We think that the bacterial pathogens present on the tonsillar surface are different from the tonsil core. And we also think that the bacteria of the tonsil surface will differ between patients undergoing adenotonsillectomy and normal controls with no adenotonsillar problems.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Children undergoing adenotonsillectomies at the Comer Children's Hospital

Description

Inclusion Criteria:

Inclusion criteria for subjects undergoing surgery:

  • Age 2-12 yrs
  • Both males and females
  • Undergoing adenotonsillectomy

Additional criteria for subjects in the recurrent infection group:

  • Sleep questionnaire score <5
  • Designated by surgeon as having recurrent adenotonsillitis as reason for surgery

Additional criteria for subjects in the airway obstruction group:

  • Sleep questionnaire score >5
  • Presence of positive polysomnogram desired but not necessary
  • Designated by surgeon as having airway obstruction or sleep apnea as reason for surgery

Inclusion criteria for control subjects:

  • Age 2-12 yrs
  • Both males and females
  • No history of adenotonsillar problems
  • Sleep questionnaire score < 5

Exclusion Criteria:

Exclusion Criteria for both groups:

  • Antibiotic intake in the past 10 days
  • Other major medical problems (immune deficiency, cystic fibrosis, malignancy) In the surgery group: designated by surgeon as having both recurrent adenotonsillitis and airway obstruction as reason for surgery Menstruating females

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Control
No tonsilar or adenoid problems
Adenotonsillectomy (recurrent)
Recurrent adenotonsillitis
Adenotonsillectomy (obstruction)
Upper airway obstruction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Fuad M Baroody, MD, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2010

Primary Completion (Actual)

February 18, 2017

Study Completion (Actual)

February 18, 2017

Study Registration Dates

First Submitted

January 3, 2011

First Submitted That Met QC Criteria

January 4, 2011

First Posted (Estimate)

January 5, 2011

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 10-636-A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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