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Bacterial Microbiota In The Tonsils Of Children

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by University of Chicago.
Recruitment status was:  Recruiting
Information provided by:
University of Chicago Identifier:
First received: January 3, 2011
Last updated: January 19, 2011
Last verified: January 2011
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 Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Bacterial Microbiota In The Tonsils Of Children Undergoing Adenotonsillectomy And Normal Controls

Further study details as provided by University of Chicago:

Estimated Enrollment: 30
Study Start Date: December 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
No tonsilar or adenoid problems
Adenotonsillectomy (recurrent)
Recurrent adenotonsillitis
Adenotonsillectomy (obstruction)
Upper airway obstruction


Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children undergoing adenotonsillectomies at the Comer Children's Hospital

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01270243

Contact: Fuad M Baroody, MD 773-702-5889

United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Principal Investigator: Fuad M Baroody, MD University of Chicago
  More Information

Responsible Party: Fuad Baroody, MD, University of Chicago Identifier: NCT01270243     History of Changes
Other Study ID Numbers: 10-636-A
Study First Received: January 3, 2011
Last Updated: January 19, 2011 processed this record on August 16, 2017