The Role of Food Sensitivity in Psoriasis

Study Overview
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Brief Summary
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Psoriasis is a common chronic skin disorder that affects over 4 million people. There is no cure for psoriasis and treatment is directed at controlling patients' symptoms. The purpose of this study is to determine whether psoriasis patients are more likely to have food sensitivities than those patients without psoriasis. We will also determine if eliminating certain foods from the diet results in a change in psoriasis symptoms.

Detailed Description
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Purpose: To determine the role of food sensitivity in psoriasis and assess the clinical response of an individualized elimination diet on psoriasis. Design: Up to 50 volunteers with psoriasis and 20 age- and sex-matched controls will be recruited for a 12-week prospective correlational study. Methods: Venous blood samples for the detection of antibodies against food antigens will be collected and individualized elimination diets will be designed based on the most reactive food antigens. Assessments: Clinical assessments of objective and subjective parameters will be measured using Psoriasis Area and Severity Index (PASI), Static Physicians Global Assessment (sPGA), Dermatology Life Quality Index (DLQI), and Itch Numeric Rating Scale (Itch NRS). Objectives: The primary objectives are to determine whether psoriasis patients are more likely to have food sensitivities and assess the clinical response of a 12-week elimination diet on psoriasis.

Official Title
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The Role of Food Sensitivity in Psoriasis: a 12-week Prospective Correlational Study of the Impact of an Individualized Elimination Diet on Disease Severity

Conditions
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Psoriasis

Intervention / Treatment
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* Other: 12-week elimination diet


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Male or female subjects, 12 years of age or older. Good general health. Willingness and ability to follow the protocol. Signed Informed Consent Form, written and witnessed. Psoriatic group only: Chronic plaque psoriasis (patients must have diagnosis for at least 6 months) or guttate psoriasis involving 2 % or greater total body surface area or 2 plaques, each measuring > 8 cm2. Psoriatic group only: Psoriasis is untreated (as defined in Exclusion criteria 4) or subject has been on a stable topical or systemic treatment with no dose alteration or regimen alteration for >12 months. Exclusion criteria: History of drug-induced psoriasis or pustular psoriasis. Moderate or severe psoriasis warranting systemic immunosuppression or inpatient admission. Pregnant, lactating, history of diabetes mellitus, thyroid disease or inflammatory bowel disease. Psoriatic group only: Use of biologic treatment for psoriasis within 3 months of baseline, use of systemic immunosuppressive treatment for psoriasis within 4 weeks of baseline, or use of topical treatment for psoriasis within 2 weeks.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psoriasis<br>Psoriasis patients will be placed on an individualized 12-week elimination diet | Other: 12-week elimination diet<br>* individualized 12-week elimination diet based on the 4 most reactive foods +/- a gluten-free diet if there is detection of positive anti- tissue transglutaminase (tTG) IgG and IgA and anti-deamidated gliadin peptide (DGP) IgG and IgA<br>|
| No Intervention: Healthy Control<br>Healthy Control patients will receive no intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IgG4 Antibodies | IgG4 Antibodies against Eliminated Food Antigens in Psoriasis Patients vs. Controls | 12 weeks | 
| IgE Antibodies | IgE Antibodies against Eliminated Food Antigens in Psoriasis Patients vs. Controls | 12 weeks | 
| Anti-Tissue Transglutaminase (tTG) IgG | Anti-Tissue Transglutaminase (tTG) IgG Change from Baseline in Psoriasis Patients vs. Controls | 12 weeks | 
| Anti-Tissue Transglutaminase (tTG) IgA | Anti-Tissue Transglutaminase (tTG) IgA Change from Baseline in Psoriasis Patients vs. Controls | 12 weeks | 
| Anti-Deamidated Gliadin Peptide (DGP) IgG | Anti-Deamidated Gliadin Peptide (DGP) IgG Change from Baseline in Psoriasis Patients vs. Controls | 12 weeks | 
| Anti-Deamidated Gliadin Peptide (DGP) IgA | Anti-Deamidated Gliadin Peptide (DGP) IgA Change from Baseline in Psoriasis Patients vs. Controls | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IgG4 Antibodies in Subset | IgG4 Antibodies against Eliminated Food Antigens in Subset of Psoriasis Patients with positive test result who participated in dietary elimination intervention | 12 weeks | 
| IgE Antibodies in Subset | IgE Antibodies against Eliminated Food Antigens in Subset of Psoriasis Patients with positive test result who participated in dietary elimination intervention | 12 weeks | 
| Anti-Tissue Transglutaminase (tTG) IgG in Subset | Anti-Tissue Transglutaminase (tTG) IgG in Subset of Psoriasis Patients with positive test result who participated in dietary elimination intervention | 12 weeks | 
| Anti-Tissue Transglutaminase (tTG) IgA in Subset | Anti-Tissue Transglutaminase (tTG) IgA in Subset of Psoriasis Patients with positive test result who participated in dietary elimination intervention | 12 weeks | 
| Anti-Deamidated Gliadin Peptide (DGP) IgG in Subset | Anti-Deamidated Gliadin Peptide (DGP) IgG in Subset of Psoriasis Patients with positive test result who participated in dietary elimination intervention | 12 weeks | 
| Anti-Deamidated Gliadin Peptide (DGP) IgA in Subset | Anti-Deamidated Gliadin Peptide (DGP) IgA in Subset of Psoriasis Patients with positive test result who participated in dietary elimination intervention | 12 weeks |