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Bacterial Microbiota In The Tonsils Of Children

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ClinicalTrials.gov Identifier: NCT01270243
Recruitment Status : Unknown
Verified January 2011 by University of Chicago.
Recruitment status was:  Recruiting
First Posted : January 5, 2011
Last Update Posted : January 21, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease
Adenotonsillitis

Study Design

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Bacterial Microbiota In The Tonsils Of Children Undergoing Adenotonsillectomy And Normal Controls
Study Start Date : December 2010
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : December 2011
Groups and Cohorts

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


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Fuad Baroody, MD, University of Chicago
ClinicalTrials.gov Identifier: NCT01270243     History of Changes
Other Study ID Numbers: 10-636-A
First Posted: January 5, 2011    Key Record Dates
Last Update Posted: January 21, 2011
Last Verified: January 2011