Clinical trial NCT03084146: The Role of Food Sensitivity in Psoriasis
Official title: The Role of Food Sensitivity in Psoriasis: a 12-week Prospective Correlational Study of the Impact of an Individualized Elimination Diet on Disease Severity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2017-03-20
Enrollment: 51
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: IgG4 Antibodies
timeFrame: 12 weeks
measure: IgE Antibodies
timeFrame: 12 weeks
measure: Anti-Tissue Transglutaminase (tTG) IgG
timeFrame: 12 weeks
measure: Anti-Tissue Transglutaminase (tTG) IgA
timeFrame: 12 weeks
measure: Anti-Deamidated Gliadin Peptide (DGP) IgG
timeFrame: 12 weeks
measure: Anti-Deamidated Gliadin Peptide (DGP) IgA
timeFrame: 12 weeks
Secondary outcomes:
measure: IgG4 Antibodies in Subset
timeFrame: 12 weeks
measure: IgE Antibodies in Subset
timeFrame: 12 weeks
measure: Anti-Tissue Transglutaminase (tTG) IgG in Subset
timeFrame: 12 weeks
measure: Anti-Tissue Transglutaminase (tTG) IgA in Subset
timeFrame: 12 weeks
measure: Anti-Deamidated Gliadin Peptide (DGP) IgG in Subset
timeFrame: 12 weeks
measure: Anti-Deamidated Gliadin Peptide (DGP) IgA in Subset
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Department of Dermatology
state: Michigan
Study officials:
affiliation: University of Michigan
name: Yolanda Helfrich, MD
role: PRINCIPAL_INVESTIGATOR
References: