PsoriasisNCT03084146
The Role of Food Sensitivity in Psoriasis
A study testing 12-week elimination diet in people with Psoriasis, run by University of Michigan at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- 12-week elimination diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2017to 22 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Department of Dermatology
Ann Arbor, Michigan, 48109
About this study
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
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.
Read the 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.
- Conditions
- Psoriasis
- Being tested
- 12-week elimination diet
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-week elimination dietOther
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 group | Role | What they receive |
|---|---|---|
| Psoriasis | Experimental | Psoriasis patients will be placed on an individualized 12-week elimination diet Receives: Other: 12-week elimination diet |
| Healthy Control | No intervention | Healthy Control patients will receive no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
IgG4 Antibodies
IgG4 Antibodies against Eliminated Food Antigens in Psoriasis Patients vs. Controls
Measured: 12 weeks
IgE Antibodies
IgE Antibodies against Eliminated Food Antigens in Psoriasis Patients vs. Controls
Measured: 12 weeks
Anti-Tissue Transglutaminase (tTG) IgG
Anti-Tissue Transglutaminase (tTG) IgG Change from Baseline in Psoriasis Patients vs. Controls
Measured: 12 weeks
Anti-Tissue Transglutaminase (tTG) IgA
Anti-Tissue Transglutaminase (tTG) IgA Change from Baseline in Psoriasis Patients vs. Controls
Measured: 12 weeks
Anti-Deamidated Gliadin Peptide (DGP) IgG
Anti-Deamidated Gliadin Peptide (DGP) IgG Change from Baseline in Psoriasis Patients vs. Controls
Measured: 12 weeks
Anti-Deamidated Gliadin Peptide (DGP) IgA
Anti-Deamidated Gliadin Peptide (DGP) IgA Change from Baseline in Psoriasis Patients vs. Controls
Measured: 12 weeks
Secondary outcomes (6)
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
Measured: 12 weeks
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
Measured: 12 weeks
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
Measured: 12 weeks
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
Measured: 12 weeks
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
Measured: 12 weeks
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study start28 Aug 2017
- Primary completion22 Oct 2023
- Study completion22 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yolanda Rosi Helfrich, University of Michigan
- Investigators
- Yolanda Helfrich, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084146
- Sponsor's protocol ID
- Derm 685/HUM00115672
- Status last verified
- May 2024
- First submitted
- 23 Feb 2017
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03084146
- Acronym / sponsor ID
- Derm 685/HUM00115672
- Conditions
- Psoriasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 22 Oct 2023 (actual)
- Study completion
- 22 Oct 2023 (actual)
- First posted
- 20 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psoriasis | Experimental | Other: 12-week elimination dietPsoriasis patients will be placed on an individualized 12-week elimination diet |
| Healthy Control | No intervention | –Healthy Control patients will receive no intervention |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12-week elimination dietindividualized 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 | Other | Psoriasis |
Primary outcome
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
6 secondary outcomes
IgG4 Antibodies in Subset
Time frame: 12 weeks
IgE Antibodies in Subset
Time frame: 12 weeks
Anti-Tissue Transglutaminase (tTG) IgG in Subset
Time frame: 12 weeks
Anti-Tissue Transglutaminase (tTG) IgA in Subset
Time frame: 12 weeks
Anti-Deamidated Gliadin Peptide (DGP) IgG in Subset
Time frame: 12 weeks
Anti-Deamidated Gliadin Peptide (DGP) IgA in Subset
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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Recruiting
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Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yolanda Helfrich, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12-week elimination diet in people with Psoriasis, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IgG4 Antibodies (time frame: 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.