AdenotonsillitisNCT01270243
Bacterial Microbiota In The Tonsils Of Children
An observational study of Adenotonsillitis, run by University of Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Adenotonsillitis
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2010to 18 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Children undergoing adenotonsillectomies at the Comer Children's Hospital
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Adenotonsillitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | No tonsilar or adenoid problems | |
| Adenotonsillectomy (recurrent) | Recurrent adenotonsillitis | |
| Adenotonsillectomy (obstruction) | Upper airway obstruction |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study start1 Dec 2010
- Primary completion18 Feb 2017
- Study completion18 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenotonsillitisStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fuad M Baroody, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270243
- Sponsor's protocol ID
- 10-636-A
- Status last verified
- Apr 2023
- First submitted
- 3 Jan 2011
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Microbiota In The Tonsils Of Children Undergoing Adenotonsillectomy And Normal Controls
- ClinicalTrials.gov ID
- NCT01270243
- Acronym / sponsor ID
- 10-636-A
- Conditions
- Adenotonsillitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 1 Dec 2010 (actual)
- Primary completion
- 18 Feb 2017 (actual)
- Study completion
- 18 Feb 2017 (actual)
- First posted
- 5 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | –No tonsilar or adenoid problems |
| Adenotonsillectomy (recurrent) | – | –Recurrent adenotonsillitis |
| Adenotonsillectomy (obstruction) | – | –Upper airway obstruction |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children undergoing adenotonsillectomies at the Comer Children's Hospital
Key inclusion criteria (14 listed)
- Age 2-12 yrs
- Both males and females
- Undergoing adenotonsillectomy
- Sleep questionnaire score <5
- Designated by surgeon as having recurrent adenotonsillitis as reason for surgery
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fuad M Baroody, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenotonsillitis, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.