Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00438646
Status:
COMPLETED
Last Update Posted:
2009-08-25
First Post:
2007-02-21
Brief Title:
Oral Bacteria and Allergic Disease in Children
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Oral Bacteria and History of Allergic Disease in Children A Pilot Study
Status:
COMPLETED
Status Verified Date:
2008-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 childs 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
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 childs 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 US 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 US 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 parents consent and the childs assent and administer a questionnaire to the parent The childs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 07-E-N109 | None | None | None |