Bacterial Microbiota In The Tonsils Of Children

Adenotonsillitis Clinical Trial

Official title:

Bacterial Microbiota In The Tonsils Of Children Undergoing Adenotonsillectomy And Normal Controls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01270243
• Other study ID #: 10-636-A
• Status: Completed
• Start date: December 1, 2010
• Est. completion date: February 18, 2017

Study information

• Verified date: April 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 18, 2017
• Est. primary completion date: February 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenotonsillitis

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States,