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AsthmaNCT00438646

Oral Bacteria and Allergic Disease in Children

An observational study of Asthma and Rhinitis, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will see if bacteria differ between children who have allergies or asthma and children who do not have allergies or asthma. Previous research suggests that some bacteria may protect against allergies and asthma. This study may provide more information on why some children develop allergies and asthma. Read more about this study

Who is it for?
Ages 6 to 11 years
Conditions the study is for
Asthma, Rhinitis, Eczema
How many people
60 participants
Where
1 siteUnited States
Study dates
Feb 2007to Dec 2008
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 6 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Aged 6-11 years.
  • Child is presenting to the UNC-CH School of Dentistry for a scheduled appointment.
  • Sibling has not been enrolled.
  • Parent consents to child's participation.
  • Parent is willing to provide answers to a questionnaire.
  • Child assents to the study.
  • Child is willing and able to provide a usable saliva sample.

Who cannot join

  • Child is unwilling or unable to provide a usable saliva sample.
  • Parent or child is non-English speaking.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina

Other trials in United States

About this study

Official title: Oral Bacteria and History of Allergic Disease in Children: A Pilot Study

This study will see if bacteria differ between children who have allergies or asthma and children who do not have allergies or asthma. Previous research suggests that some bacteria may protect against allergies and asthma. This study may provide more information on why some children develop allergies and asthma.

Patients at the University of North Carolina-Chapel Hill School of Dentistry who are between 6 and 11 years of age may be eligible for this study.

Read more

Parents of participating children complete a questionnaire about the child and the child's health. The child provides a saliva sample by chewing a small piece of wax and spitting in a cup.

The saliva sample is analyzed in the laboratory for bacteria, yeast and antibodies (substances the body produces to fight germs).

...

Read the detailed description

The purpose of this study is to examine the feasibility of and to establish methods for a future study that will investigate associations between oral bacteria and allergic diseases in children. Rates of allergic diseases such as asthma, hay fever, and eczema have increased in the U.S. over the past several decades. One explanation for those increases is the Hygiene Hypothesis, which contends that decreases in microbial exposures have made the population more reactive to environmental allergens. Reports of protective associations for various infections and exposures to farms, pets, siblings, and day care have provided support for the Hypothesis. Preliminary work by NIEHS researchers suggests that some oral bacterial exposures may be beneficial. NIEHS researchers recently reported that elevated serum antibody concentrations to two common oral pathogens were associated with lower prevalences of asthma, wheeze, and hay fever in the U.S. population. Using a mouse model, NIEHS researchers found that immune responses involved in allergic airway inflammation could be modulated by infection with an oral pathogen. To further investigate these associations in humans, NIEHS researchers, in collaboration with UNC researchers, are planning an observational study that will collect saliva samples from and allergy information on child patients at the UNC-Chapel Hill School of Dentistry. Because we anticipate that several hundred children might have to be enrolled, we are proposing to test methods in a pilot study of 60 children. Twenty children will be recruited from each of three pediatric clinics. A research assistant will obtain the parent's consent and the child's assent and administer a questionnaire to the parent. The child's dentist will collect one teaspoon of saliva by having the child chew a piece of inert wax and spit into a sterile collection cup. Samples will be transported to the NIEHS and analyzed for bacterial species and for allergy-related cytokines. The specific aims for this pilot study are: 1) to identify the most efficient recruitment strategies, 2) to estimate response rates, 3) to estimate the distribution of allergic diseases among the children, 4) to identify any problematic consent form and questionnaire items, 5) to optimize saliva collection and laboratory protocols, and 6) to estimate statistical parameters required for more precise sample size calculations. Information gained from this pilot study will allow us to decide whether a larger study among this clinic population is feasible and to design a more efficient study if we decide to proceed.

Keywords
Allergy, Asthma, Eczema, Hay Fever, Epidemiology
Medical subject headings
Asthma, Rhinitis, Eczema, Respiratory Sounds, Hypersensitivity, Rhinitis, Allergic, Seasonal

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2007 (estimated)
  2. Study startFeb 2007
  3. Primary completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
60 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00438646
Sponsor's protocol ID
999907109
Other IDs
07-E-N109
Status last verified
Nov 2008
First submitted
21 Feb 2007
Last updated
25 Aug 2009
Results posted
No

Publications

  • Mannino DM, Homa DM, Akinbami LJ, Moorman JE, Gwynn C, Redd SC. Surveillance for asthma--United States, 1980-1999. MMWR Surveill Summ. 2002 Mar 29;51(1):1-13.

    PubMed 12420904
  • Arbes SJ Jr, Gergen PJ, Elliott L, Zeldin DC. Prevalences of positive skin test responses to 10 common allergens in the US population: results from the third National Health and Nutrition Examination Survey. J Allergy Clin Immunol. 2005 Aug;116(2):377-83. doi: 10.1016/j.jaci.2005.05.017.

    PubMed 16083793
  • Liu AH, Murphy JR. Hygiene hypothesis: fact or fiction? J Allergy Clin Immunol. 2003 Mar;111(3):471-8. doi: 10.1067/mai.2003.172.

    PubMed 12642824

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma and Rhinitis, run by National Institute of Environmental Health Sciences (NIEHS) 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 7 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 25 Aug 2009. 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?

On the ClinicalTrials.gov record for NCT00438646, which also lists 3 linked publications.

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 25 Aug 2009.

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