University of Michigan Department of Dermatology
Ann Arbor, Michigan, 48109, United States
NCT Number: NCT03084146
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.
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Notify Me12 year and older
All sexes
Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 12 weeks
IgG4 Antibodies against Eliminated Food Antigens in Psoriasis Patients vs. Controls
Time frame: 12 weeks
IgE Antibodies against Eliminated Food Antigens in Psoriasis Patients vs. Controls
Time frame: 12 weeks
Anti-Tissue Transglutaminase (tTG) IgG Change from Baseline in Psoriasis Patients vs. Controls
Time frame: 12 weeks
Anti-Tissue Transglutaminase (tTG) IgA Change from Baseline in Psoriasis Patients vs. Controls
Time frame: 12 weeks
Anti-Deamidated Gliadin Peptide (DGP) IgG Change from Baseline in Psoriasis Patients vs. Controls
Time frame: 12 weeks
Anti-Deamidated Gliadin Peptide (DGP) IgA Change from Baseline in Psoriasis Patients vs. Controls
Time frame: 12 weeks
IgG4 Antibodies against Eliminated Food Antigens in Subset of Psoriasis Patients with positive test result who participated in dietary elimination intervention
Time frame: 12 weeks
IgE Antibodies against Eliminated Food Antigens in Subset of Psoriasis Patients with positive test result who participated in dietary elimination intervention
Time frame: 12 weeks
Anti-Tissue Transglutaminase (tTG) IgG in Subset of Psoriasis Patients with positive test result who participated in dietary elimination intervention
Time frame: 12 weeks
Anti-Tissue Transglutaminase (tTG) IgA in Subset of Psoriasis Patients with positive test result who participated in dietary elimination intervention
Time frame: 12 weeks
Anti-Deamidated Gliadin Peptide (DGP) IgG in Subset of Psoriasis Patients with positive test result who participated in dietary elimination intervention
Time frame: 12 weeks
Anti-Deamidated Gliadin Peptide (DGP) IgA in Subset of Psoriasis Patients with positive test result who participated in dietary elimination intervention
University of Michigan
Other
The Role of Food Sensitivity in Psoriasis: a 12-week Prospective Correlational Study of the Impact of an Individualized Elimination Diet on Disease Severity
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