The Role of Food Sensitivity in Psoriasis

NCT03084146 | Completed

• 1 other identifier: Derm 685/HUM00115672
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (6)

• IgG4 Antibodies

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

  12 weeks

• IgE Antibodies

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

  12 weeks

• Anti-Tissue Transglutaminase (tTG) IgG

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

  12 weeks

• Anti-Tissue Transglutaminase (tTG) IgA

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

  12 weeks

• Anti-Deamidated Gliadin Peptide (DGP) IgG

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

  12 weeks

• Anti-Deamidated Gliadin Peptide (DGP) IgA

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

  12 weeks

Secondary Outcomes (6)

• IgG4 Antibodies in Subset

  12 weeks

• IgE Antibodies in Subset

  12 weeks

• Anti-Tissue Transglutaminase (tTG) IgG in Subset

  12 weeks

• Anti-Tissue Transglutaminase (tTG) IgA in Subset

  12 weeks

• Anti-Deamidated Gliadin Peptide (DGP) IgG in Subset

  12 weeks

Study Arms (2)

Psoriasis

EXPERIMENTAL

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

Other: 12-week elimination diet

Healthy Control

NO INTERVENTION

Healthy Control patients will receive no intervention

Interventions

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

Psoriasis

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Department of Dermatology

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Elimination Diets

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Yolanda Helfrich, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Program for Clinical Research In Dermatology

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: March 20, 2017
• Study Start: August 28, 2017
• Primary Completion: October 22, 2023
• Study Completion: October 22, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)