The Role of Food Sensitivity in Psoriasis

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03084146
• Other study ID #: Derm 685/HUM00115672
• Status: Completed
• Phase: N/A
• Start date: August 28, 2017
• Est. completion date: October 22, 2023

Study information

• Verified date: May 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: October 22, 2023
• Est. primary completion date: October 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• 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

Locations

Country	Name	City	State
United States	University of Michigan Department of Dermatology	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IgG4 Antibodies	IgG4 Antibodies against Eliminated Food Antigens in Psoriasis Patients vs. Controls	12 weeks
Primary	IgE Antibodies	IgE Antibodies against Eliminated Food Antigens in Psoriasis Patients vs. Controls	12 weeks
Primary	Anti-Tissue Transglutaminase (tTG) IgG	Anti-Tissue Transglutaminase (tTG) IgG Change from Baseline in Psoriasis Patients vs. Controls	12 weeks
Primary	Anti-Tissue Transglutaminase (tTG) IgA	Anti-Tissue Transglutaminase (tTG) IgA Change from Baseline in Psoriasis Patients vs. Controls	12 weeks
Primary	Anti-Deamidated Gliadin Peptide (DGP) IgG	Anti-Deamidated Gliadin Peptide (DGP) IgG Change from Baseline in Psoriasis Patients vs. Controls	12 weeks
Primary	Anti-Deamidated Gliadin Peptide (DGP) IgA	Anti-Deamidated Gliadin Peptide (DGP) IgA Change from Baseline in Psoriasis Patients vs. Controls	12 weeks
Secondary	IgG4 Antibodies in Subset	IgG4 Antibodies against Eliminated Food Antigens in Subset of Psoriasis Patients with positive test result who participated in dietary elimination intervention	12 weeks
Secondary	IgE Antibodies in Subset	IgE Antibodies against Eliminated Food Antigens in Subset of Psoriasis Patients with positive test result who participated in dietary elimination intervention	12 weeks
Secondary	Anti-Tissue Transglutaminase (tTG) IgG in Subset	Anti-Tissue Transglutaminase (tTG) IgG in Subset of Psoriasis Patients with positive test result who participated in dietary elimination intervention	12 weeks
Secondary	Anti-Tissue Transglutaminase (tTG) IgA in Subset	Anti-Tissue Transglutaminase (tTG) IgA in Subset of Psoriasis Patients with positive test result who participated in dietary elimination intervention	12 weeks
Secondary	Anti-Deamidated Gliadin Peptide (DGP) IgG in Subset	Anti-Deamidated Gliadin Peptide (DGP) IgG in Subset of Psoriasis Patients with positive test result who participated in dietary elimination intervention	12 weeks
Secondary	Anti-Deamidated Gliadin Peptide (DGP) IgA in Subset	Anti-Deamidated Gliadin Peptide (DGP) IgA in Subset of Psoriasis Patients with positive test result who participated in dietary elimination intervention	12 weeks