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Bacterial Microbiota In The Tonsils Of Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University of Chicago.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT01270243
First received: January 3, 2011
Last updated: January 19, 2011
Last verified: January 2011
History of Changes
  Purpose

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.


Condition
Adenotonsillitis

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

Resource links provided by NLM:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Children undergoing adenotonsillectomies at the Comer Children's Hospital

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01270243

Contacts
Contact: Fuad M Baroody, MD 773-702-5889 fbaroody@surgery.bsd.uchicago.edu

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

No publications provided

Responsible Party: Fuad Baroody, MD, University of Chicago
ClinicalTrials.gov Identifier: NCT01270243     History of Changes
Other Study ID Numbers: 10-636-A
Study First Received: January 3, 2011
Last Updated: January 19, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 22, 2013