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Transcript of Design
A lack of early childhood exposure to infectious agents, symbiotic microorganisms,and parasites increases susceptibility to allergic diseases by suppressing the natural development of the immune system
Helminthic Therapy mediating the Bodies Immune Response to Allergens
This study aims to demonstrate that infestation with small amounts of hookworms will alleviate the symptoms of seasonal allergies
Third World- 65.6 yrs
US- 6/ 1000
Third World 13.5/1000
In the US, allergic diseases have been on the rise for 50 yrs
36 million people suffer from seasonal allergies.
Do Hookworm infestations decrease the symptoms of seasonal allergies?
Participants infested with hookworms will not show reduced markers of allergies when compared to the control group
. In 2013 the Allergy Foundation of America ranked US cities by the severity of their fall allergy season.
- Fall pollen levels (specific to region)
- Use of over-the-counter and prescription allergy medication
- Number of board certified allergists in each city.
. To account for the different allergens in each region, the top five ranking cities were chosen from the Northeast, Midwest, West and South
6 month prospective study
100 participants in each city
Hookworm exposure will take place in June (10 hookworms)
Hookworm/placebo will be applied to arm via a bandage (36 hrs)
Incubation period of 3 months
Fecal sample will be taken to confirm infestation
Measurements will be taken between September and November
Neither group will take normal allergy medication during study
Hookworm eggs will appear in the feces of infested participants
Eggs range in size from 55 um to 90 um
may be 7-9 mm
Participants who become aware of their infestation will be placed in a subgroup
20 participating cities
Analysis will be done between test and control groups within the same city
National analysis will be done controlling for different allergens
Subgroups of infested participants will be compared
Buffalo NY(16), Syracuse NY(25), Providence RI(28), Rochester NY(35), Portland ME(39)
Wichita KS(1), Dayton OH(8), Madison WI(12), Omaha NE(13) Grand Rapids MI(17)
Riverside CA(47), Fresno CA(64), Las Vegas NV(70),Phoenix AZ(72), Tucson AZ(73)
Jackson MS(2), Knoxville TN(3), Louisville KY(4), Memphis TN(5), McAllen TX(5)
Participants will be recruited by:
Flyers in clinics & universities
Advertisements on public transportation
Participants will be paid for their participation
All participants will sign a waiver before study begins
Diagnosed by a physician as moderate to severe seasonal allergies
- This will be verified by a board certified allergist upon participant presentation
Confounding medical pathologies such as, asthma not brought on my seasonal allergies
Previous history of parasitic infection
People who consume 2 or more alcoholic beverages daily
Females who are, or intend to become pregnant during the study
After recruitment is complete stratified randomization will be done to select participants
Block randomization will be used to divide the cohorts into test and control groups
Triple blind study
Demographic and Clinical Assessment
Allergen-Specific Immunoglobulin Blood Test
Baseline and demographic data collected before exposure
Control and test groups will be matched as closely as possible on the basis of: gender, age, ethnicity and specific exposure (neighborhood)
Allergen-Specific IgE antibodies (according to region) will be measured biweekly.
For qualitative assessment a scratch test will be performed at the start and end of the study
Levels of Analysis
- 3 month mean values of Allergen-Specific IgE
Inter/intra city Analysis
General Linearized model
- Poisson Regression
- Different levels of IgE will be related to different allergens
- When comparing different regions it will be necessary to control for different levels of IgE
T Test between subgroups of infested participants
We expect to show that infested partipants will show lower levels of Allergen-Specif IgE in their blood and reduced allergic symptoms