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Design

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by

Matthew Carroll

on 3 April 2014

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Transcript of Design

Hookworm- Nectar Americanus
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
Methods
Design
Participants
Measurements
Analysis
Helminthic Therapy mediating the Bodies Immune Response to Allergens
Introduction
Hygiene Theory
Aims
This study aims to demonstrate that infestation with small amounts of hookworms will alleviate the symptoms of seasonal allergies
Life expectancy
US- 78.7yrs
Third World- 65.6 yrs
Infant Mortality
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?
Question
Null Hypothesis
Participants infested with hookworms will not show reduced markers of allergies when compared to the control group
Design
Participants
. 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


Measurements
Analysis
6 month prospective study
20 cities
100 participants in each city
Design
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
Intervention
Hookworm eggs will appear in the feces of infested participants
Eggs range in size from 55 um to 90 um
Nectar americanus
may be 7-9 mm
Participants who become aware of their infestation will be placed in a subgroup
Subgroup
20 participating cities
2000 participants
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
Overall Design
Northeast:
Buffalo NY(16), Syracuse NY(25), Providence RI(28), Rochester NY(35), Portland ME(39)
Midwest:
Wichita KS(1), Dayton OH(8), Madison WI(12), Omaha NE(13) Grand Rapids MI(17)
West:
Riverside CA(47), Fresno CA(64), Las Vegas NV(70),Phoenix AZ(72), Tucson AZ(73)
South:
Jackson MS(2), Knoxville TN(3), Louisville KY(4), Memphis TN(5), McAllen TX(5)
Participating Cities
Recruitment
Inclusion Criteria
Exclusion Criteria
Randomization
Participants will be recruited by:
Flyers in clinics & universities
Newspaper ads
Radio ads
Advertisements on public transportation

Participants will be paid for their participation


All participants will sign a waiver before study begins





Aged 25-35
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
Smokers
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
Biweekly evaluation
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
Intra-city
Inter-city
National

Continuous variable


-Subgroup
Levels of Analysis
T-test
- 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
National Analysis
T Test between subgroups of infested participants
Subgroup Analysis
We expect to show that infested partipants will show lower levels of Allergen-Specif IgE in their blood and reduced allergic symptoms
Summary Analysis
Full transcript