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The Role of Food Sensitivity in Psoriasis

Not Applicable
Completed
Conditions
Psoriasis
Interventions
Other: 12-week elimination diet
Registration Number
NCT03084146
Lead Sponsor
University of Michigan
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
51
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Psoriasis12-week elimination dietPsoriasis patients will be placed on an individualized 12-week elimination diet
Primary Outcome Measures
NameTimeMethod
IgE Antibodies12 weeks

IgE Antibodies against Eliminated Food Antigens in Psoriasis Patients vs. Controls

Anti-Tissue Transglutaminase (tTG) IgA12 weeks

Anti-Tissue Transglutaminase (tTG) IgA Change from Baseline in Psoriasis Patients vs. Controls

Anti-Deamidated Gliadin Peptide (DGP) IgA12 weeks

Anti-Deamidated Gliadin Peptide (DGP) IgA Change from Baseline in Psoriasis Patients vs. Controls

IgG4 Antibodies12 weeks

IgG4 Antibodies against Eliminated Food Antigens in Psoriasis Patients vs. Controls

Anti-Tissue Transglutaminase (tTG) IgG12 weeks

Anti-Tissue Transglutaminase (tTG) IgG Change from Baseline in Psoriasis Patients vs. Controls

Anti-Deamidated Gliadin Peptide (DGP) IgG12 weeks

Anti-Deamidated Gliadin Peptide (DGP) IgG Change from Baseline in Psoriasis Patients vs. Controls

Secondary Outcome Measures
NameTimeMethod
Anti-Deamidated Gliadin Peptide (DGP) IgG in Subset12 weeks

Anti-Deamidated Gliadin Peptide (DGP) IgG in Subset of Psoriasis Patients with positive test result who participated in dietary elimination intervention

Anti-Tissue Transglutaminase (tTG) IgG in Subset12 weeks

Anti-Tissue Transglutaminase (tTG) IgG in Subset of Psoriasis Patients with positive test result who participated in dietary elimination intervention

IgG4 Antibodies in Subset12 weeks

IgG4 Antibodies against Eliminated Food Antigens in Subset of Psoriasis Patients with positive test result who participated in dietary elimination intervention

Anti-Tissue Transglutaminase (tTG) IgA in Subset12 weeks

Anti-Tissue Transglutaminase (tTG) IgA in Subset of Psoriasis Patients with positive test result who participated in dietary elimination intervention

IgE Antibodies in Subset12 weeks

IgE Antibodies against Eliminated Food Antigens in Subset of Psoriasis Patients with positive test result who participated in dietary elimination intervention

Anti-Deamidated Gliadin Peptide (DGP) IgA in Subset12 weeks

Anti-Deamidated Gliadin Peptide (DGP) IgA in Subset of Psoriasis Patients with positive test result who participated in dietary elimination intervention

Trial Locations

Locations (1)

University of Michigan Department of Dermatology

🇺🇸

Ann Arbor, Michigan, United States

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