Bacterial Microbiota In The Tonsils Of Children

NCT ID: NCT01270243

Last Updated: 2023-04-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-12-01
• Study Completion Date: 2017-02-18

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 Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Control

No tonsilar or adenoid problems

No interventions assigned to this group

Adenotonsillectomy (recurrent)

Recurrent adenotonsillitis

No interventions assigned to this group

Adenotonsillectomy (obstruction)

Upper airway obstruction

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fuad M Baroody, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

10-636-A

Identifier Type: -

Identifier Source: org_study_id