The Role of Food Sensitivity in Psoriasis

• ClinicalTrials.gov Identifier: NCT03084146
• Recruitment Status: Recruiting
• First Posted: March 20, 2017
• Last Update Posted: May 19, 2022
• Sponsor: University of Michigan
• Information provided by (Responsible Party): Yolanda Rosi Helfrich, University of Michigan

Tracking Information

• First Submitted Date: February 23, 2017
• First Posted Date: March 20, 2017
• Last Update Posted Date: May 19, 2022
• Actual Study Start Date: August 28, 2017
• Estimated Primary Completion Date: May 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 13, 2017)

• IgG4 Antibodies [ Time Frame: 12 weeks ]
  IgG4 Antibodies against Eliminated Food Antigens in Psoriasis Patients vs. Controls
• IgE Antibodies [ Time Frame: 12 weeks ]
  IgE Antibodies against Eliminated Food Antigens in Psoriasis Patients vs. Controls
• Anti-Tissue Transglutaminase (tTG) IgG [ Time Frame: 12 weeks ]
  Anti-Tissue Transglutaminase (tTG) IgG Change from Baseline in Psoriasis Patients vs. Controls
• Anti-Tissue Transglutaminase (tTG) IgA [ Time Frame: 12 weeks ]
  Anti-Tissue Transglutaminase (tTG) IgA Change from Baseline in Psoriasis Patients vs. Controls
• Anti-Deamidated Gliadin Peptide (DGP) IgG [ Time Frame: 12 weeks ]
  Anti-Deamidated Gliadin Peptide (DGP) IgG Change from Baseline in Psoriasis Patients vs. Controls
• Anti-Deamidated Gliadin Peptide (DGP) IgA [ Time Frame: 12 weeks ]
  Anti-Deamidated Gliadin Peptide (DGP) IgA Change from Baseline in Psoriasis Patients vs. Controls

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 13, 2017)

• 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
• 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
• 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
• 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
• 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
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Psoriasis

Intervention

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

Study Arms

• Experimental: Psoriasis
  Psoriasis patients will be placed on an individualized 12-week elimination diet
  Intervention: Other: 12-week elimination diet
• No Intervention: Healthy Control
  Healthy Control patients will receive no intervention

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 13, 2017): 70
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2023
• Estimated Primary Completion Date: May 2023 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Nicole Nechiporchik; 734-936-7519; nnechipo@med.umich.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03084146
• Other Study ID Numbers: Derm 685/HUM00115672
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Yolanda Rosi Helfrich, University of Michigan
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Michigan
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Yolanda Helfrich, MD; University of Michigan

• PRS Account: University of Michigan
• Verification Date: May 2022