Bacterial Microbiota In The Tonsils Of Children

NCT01270243 | Completed DMC

• 1 other identifier: 10-636-A
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenotonsillitis

Study Arms (3)

Control

No tonsilar or adenoid problems

Adenotonsillectomy (recurrent)

Recurrent adenotonsillitis

Adenotonsillectomy (obstruction)

Upper airway obstruction

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children undergoing adenotonsillectomies at the Comer Children's Hospital

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Study Officials

• Fuad M Baroody, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2011
• First Posted: January 5, 2011
• Study Start: December 1, 2010
• Primary Completion: February 18, 2017
• Study Completion: February 18, 2017
• Last Updated: April 26, 2023

Record last verified: 2023-04

Locations

US (1)