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The Role of Food Sensitivity in Psoriasis

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ClinicalTrials.gov Identifier: NCT03084146
Recruitment Status : Recruiting
First Posted : March 20, 2017
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Yolanda Rosi Helfrich, 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.

Condition or disease Intervention/treatment Phase
Psoriasis Other: 12-week elimination diet Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : August 28, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Psoriasis
Psoriasis patients will be placed on an individualized 12-week elimination diet
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

No Intervention: Healthy Control
Healthy Control patients will receive no intervention



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03084146


Contacts
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Contact: Jennifer Bell 734-936-4075 jennbell@umich.edu

Locations
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United States, Michigan
University of Michigan Department of Dermatology Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Jennifer Bell    734-936-4075    jennbell@med.umich.edu   
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Yolanda Helfrich, MD University of Michigan

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Responsible Party: Yolanda Rosi Helfrich, Director Program for Clinical Research In Dermatology, University of Michigan
ClinicalTrials.gov Identifier: NCT03084146     History of Changes
Other Study ID Numbers: Derm 685/HUM00115672
First Posted: March 20, 2017    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases