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Completed

NCT Number: NCT03084146

The Role of Food Sensitivity in Psoriasis

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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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Department of Dermatology

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

12-week elimination diet

Other

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

Primary outcomes

  1. IgG4 Antibodies

    Time frame: 12 weeks

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

  2. IgE Antibodies

    Time frame: 12 weeks

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

  3. Anti-Tissue Transglutaminase (tTG) IgG

    Time frame: 12 weeks

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

  4. Anti-Tissue Transglutaminase (tTG) IgA

    Time frame: 12 weeks

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

  5. Anti-Deamidated Gliadin Peptide (DGP) IgG

    Time frame: 12 weeks

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

  6. Anti-Deamidated Gliadin Peptide (DGP) IgA

    Time frame: 12 weeks

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

Secondary outcomes

  1. IgG4 Antibodies in Subset

    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

  2. IgE Antibodies in Subset

    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

  3. Anti-Tissue Transglutaminase (tTG) IgG in Subset

    Time frame: 12 weeks

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

  4. Anti-Tissue Transglutaminase (tTG) IgA in Subset

    Time frame: 12 weeks

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

  5. Anti-Deamidated Gliadin Peptide (DGP) IgG in Subset

    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

  6. Anti-Deamidated Gliadin Peptide (DGP) IgA in Subset

    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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Mar 20, 2017
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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