Clinical Trials

The Role of Food Sensitivity in Psoriasis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	12 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03084146
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Michigan
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Yolanda Helfrich, MD
Principal Investigator Affiliation	University of Michigan
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Psoriasis

Additional Details

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.

Arms & Interventions

Arms

Experimental: Psoriasis

Psoriasis patients will be placed on an individualized 12-week elimination diet

No Intervention: Healthy Control

Healthy Control patients will receive no intervention

Interventions

Other: - 12-week elimination diet

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan Department of Dermatology

Ann Arbor, Michigan, 48109

Site Contact

Nicole Nechiporchik

nnechipo@med.umich.edu

734-936-7519

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