Back to resultsThe Role of Food Sensitivity in Psoriasis
Primary Purpose
Psoriasis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
12-week elimination diet
Sponsored by
About this trial
This is an interventional basic science trial for Psoriasis
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.
Sites / Locations
- University of Michigan Department of DermatologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Psoriasis
Healthy Control
Arm Description
Psoriasis patients will be placed on an individualized 12-week elimination diet
Healthy Control patients will receive no intervention
Outcomes
Primary Outcome Measures
IgG4 Antibodies
IgG4 Antibodies against Eliminated Food Antigens in Psoriasis Patients vs. Controls
IgE Antibodies
IgE Antibodies against Eliminated Food Antigens in Psoriasis Patients vs. Controls
Anti-Tissue Transglutaminase (tTG) IgG
Anti-Tissue Transglutaminase (tTG) IgG Change from Baseline in Psoriasis Patients vs. Controls
Anti-Tissue Transglutaminase (tTG) IgA
Anti-Tissue Transglutaminase (tTG) IgA Change from Baseline in Psoriasis Patients vs. Controls
Anti-Deamidated Gliadin Peptide (DGP) IgG
Anti-Deamidated Gliadin Peptide (DGP) IgG Change from Baseline in Psoriasis Patients vs. Controls
Anti-Deamidated Gliadin Peptide (DGP) IgA
Anti-Deamidated Gliadin Peptide (DGP) IgA Change from Baseline in Psoriasis Patients vs. Controls
Secondary Outcome Measures
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
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
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03084146
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 28, 2017 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Psoriasis
Arm Type
Experimental
Arm Description
Psoriasis patients will be placed on an individualized 12-week elimination diet
Arm Title
Healthy Control
Arm Type
No Intervention
Arm Description
Healthy Control patients will receive no intervention
Intervention Type
Other
Intervention Name(s)
12-week elimination diet
Intervention Description
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 Outcome Measure Information:
Title
IgG4 Antibodies
Description
IgG4 Antibodies against Eliminated Food Antigens in Psoriasis Patients vs. Controls
Time Frame
12 weeks
Title
IgE Antibodies
Description
IgE Antibodies against Eliminated Food Antigens in Psoriasis Patients vs. Controls
Time Frame
12 weeks
Title
Anti-Tissue Transglutaminase (tTG) IgG
Description
Anti-Tissue Transglutaminase (tTG) IgG Change from Baseline in Psoriasis Patients vs. Controls
Time Frame
12 weeks
Title
Anti-Tissue Transglutaminase (tTG) IgA
Description
Anti-Tissue Transglutaminase (tTG) IgA Change from Baseline in Psoriasis Patients vs. Controls
Time Frame
12 weeks
Title
Anti-Deamidated Gliadin Peptide (DGP) IgG
Description
Anti-Deamidated Gliadin Peptide (DGP) IgG Change from Baseline in Psoriasis Patients vs. Controls
Time Frame
12 weeks
Title
Anti-Deamidated Gliadin Peptide (DGP) IgA
Description
Anti-Deamidated Gliadin Peptide (DGP) IgA Change from Baseline in Psoriasis Patients vs. Controls
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
IgG4 Antibodies in Subset
Description
IgG4 Antibodies against Eliminated Food Antigens in Subset of Psoriasis Patients with positive test result who participated in dietary elimination intervention
Time Frame
12 weeks
Title
IgE Antibodies in Subset
Description
IgE Antibodies against Eliminated Food Antigens in Subset of Psoriasis Patients with positive test result who participated in dietary elimination intervention
Time Frame
12 weeks
Title
Anti-Tissue Transglutaminase (tTG) IgG in Subset
Description
Anti-Tissue Transglutaminase (tTG) IgG in Subset of Psoriasis Patients with positive test result who participated in dietary elimination intervention
Time Frame
12 weeks
Title
Anti-Tissue Transglutaminase (tTG) IgA in Subset
Description
Anti-Tissue Transglutaminase (tTG) IgA in Subset of Psoriasis Patients with positive test result who participated in dietary elimination intervention
Time Frame
12 weeks
Title
Anti-Deamidated Gliadin Peptide (DGP) IgG in Subset
Description
Anti-Deamidated Gliadin Peptide (DGP) IgG in Subset of Psoriasis Patients with positive test result who participated in dietary elimination intervention
Time Frame
12 weeks
Title
Anti-Deamidated Gliadin Peptide (DGP) IgA in Subset
Description
Anti-Deamidated Gliadin Peptide (DGP) IgA in Subset of Psoriasis Patients with positive test result who participated in dietary elimination intervention
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Nechiporchik
Phone
734-936-7519
Email
nnechipo@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yolanda Helfrich, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Department of Dermatology
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Nechiporchik
Phone
734-936-7519
Email
nnechipo@med.umich.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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The Role of Food Sensitivity in Psoriasis
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