The Role of Food Sensitivity in Psoriasis
- 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
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Psoriasis 12-week elimination diet Psoriasis patients will be placed on an individualized 12-week elimination diet
- Primary Outcome Measures
Name Time Method IgE Antibodies 12 weeks IgE Antibodies against Eliminated Food Antigens in Psoriasis Patients vs. Controls
Anti-Tissue Transglutaminase (tTG) IgA 12 weeks Anti-Tissue Transglutaminase (tTG) IgA Change from Baseline in Psoriasis Patients vs. Controls
Anti-Deamidated Gliadin Peptide (DGP) IgA 12 weeks Anti-Deamidated Gliadin Peptide (DGP) IgA Change from Baseline in Psoriasis Patients vs. Controls
IgG4 Antibodies 12 weeks IgG4 Antibodies against Eliminated Food Antigens in Psoriasis Patients vs. Controls
Anti-Tissue Transglutaminase (tTG) IgG 12 weeks Anti-Tissue Transglutaminase (tTG) IgG Change from Baseline in Psoriasis Patients vs. Controls
Anti-Deamidated Gliadin Peptide (DGP) IgG 12 weeks Anti-Deamidated Gliadin Peptide (DGP) IgG Change from Baseline in Psoriasis Patients vs. Controls
- Secondary Outcome Measures
Name Time Method Anti-Deamidated Gliadin Peptide (DGP) IgG in Subset 12 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 Subset 12 weeks Anti-Tissue Transglutaminase (tTG) IgG in Subset of Psoriasis Patients with positive test result who participated in dietary elimination intervention
IgG4 Antibodies in Subset 12 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 Subset 12 weeks Anti-Tissue Transglutaminase (tTG) IgA in Subset of Psoriasis Patients with positive test result who participated in dietary elimination intervention
IgE Antibodies in Subset 12 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 Subset 12 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