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.
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
- 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
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.
- Conditions
- Asthma, Rhinitis, Eczema, Respiratory Sounds, Hypersensitivity
- 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.
- First posted22 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
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 12420904Arbes 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 16083793Liu 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Bacteria and History of Allergic Disease in Children: A Pilot Study
- ClinicalTrials.gov ID
- NCT00438646
- Acronym / sponsor ID
- 999907109
- Conditions
- Asthma, Rhinitis, Eczema, Respiratory Sounds, Hypersensitivity
- Keywords
- Allergy, Asthma, Eczema, Hay Fever, Epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- Feb 2007
- Primary completion
- Dec 2008 (actual)
- First posted
- 22 Feb 2007 (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.
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.
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).
...
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
Key exclusion criteria (2 listed)
- Child is unwilling or unable to provide a usable saliva sample.
- Parent or child is non-English speaking.
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 25 Aug 2009.
- Background: PubMed 12420904Mannino 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.
- Background: PubMed 16083793Arbes 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.
- Background: PubMed 12642824Liu AH, Murphy JR. Hygiene hypothesis: fact or fiction? J Allergy Clin Immunol. 2003 Mar;111(3):471-8. doi: 10.1067/mai.2003.172.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 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; AzTrials last refreshed its copy on 7 Nov 2026.