- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01270243
Bacterial Microbiota In The Tonsils Of Children
April 24, 2023 updated by: University of Chicago
Bacterial Microbiota In The Tonsils Of Children Undergoing Adenotonsillectomy And Normal Controls
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
24
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- University of Chicago
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 12 years (Child)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Children undergoing adenotonsillectomies at the Comer Children's Hospital
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Control
No tonsilar or adenoid problems
|
Adenotonsillectomy (recurrent)
Recurrent adenotonsillitis
|
Adenotonsillectomy (obstruction)
Upper airway obstruction
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fuad M Baroody, MD, University of Chicago
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2010
Primary Completion (Actual)
February 18, 2017
Study Completion (Actual)
February 18, 2017
Study Registration Dates
First Submitted
January 3, 2011
First Submitted That Met QC Criteria
January 4, 2011
First Posted (Estimate)
January 5, 2011
Study Record Updates
Last Update Posted (Actual)
April 26, 2023
Last Update Submitted That Met QC Criteria
April 24, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 10-636-A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adenotonsillitis
-
IRCCS Burlo GarofoloCompletedAuditory Intraoperative Stimulation Effects on Pain and Agitation at Awakening (AUDIOPAW) (AUDIOPAW)Procedural Pain | Procedural Anxiety | AdenotonsillitisItaly
-
Nationwide Children's HospitalCompletedTonsillitis | AdenotonsillitisUnited States