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12-week Elimination Diet for Psoriasis
N/A
Waitlist Available
Led By Yolanda Helfrich, MD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Must not have
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
Moderate or severe psoriasis warranting systemic immunosuppression or inpatient admission
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Summary
This trial will study whether people with psoriasis are more likely to have food sensitivities, and if eliminating certain foods from the diet improves psoriasis symptoms.
Who is the study for?
This trial is for males and females aged 12 or older with chronic plaque psoriasis or guttate psoriasis covering at least 2% of their body. Participants should be in good health, able to follow the study plan, and have not used certain psoriasis treatments recently. Those with severe psoriasis, recent biologic treatment use, drug-induced or pustular psoriasis, pregnancy, lactation, diabetes mellitus, thyroid disease or inflammatory bowel disease cannot join.Check my eligibility
What is being tested?
The study is testing if a 12-week elimination diet can improve symptoms in people with psoriasis by removing foods they may be sensitive to. It aims to see if food sensitivities are more common in those with this skin condition compared to those without it.See study design
What are the potential side effects?
Potential side effects from the dietary changes could include nutritional deficiencies or reactions when reintroducing foods after elimination. However, specific side effects will depend on which foods are eliminated.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had psoriasis for at least 6 months, covering more than 2% of my body or two large areas.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have used treatments for psoriasis recently.
Select...
My psoriasis is severe enough to need stronger medication or hospital care.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Anti-Deamidated Gliadin Peptide (DGP) IgA
Anti-Deamidated Gliadin Peptide (DGP) IgG
Anti-Tissue Transglutaminase (tTG) IgA
+3 moreSecondary outcome measures
Anti-Deamidated Gliadin Peptide (DGP) IgA in Subset
Anti-Deamidated Gliadin Peptide (DGP) IgG in Subset
Anti-Tissue Transglutaminase (tTG) IgA in Subset
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PsoriasisExperimental Treatment1 Intervention
Psoriasis patients will be placed on an individualized 12-week elimination diet
Group II: Healthy ControlActive Control1 Intervention
Healthy Control patients will receive no intervention
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,817 Previous Clinical Trials
6,387,311 Total Patients Enrolled
6 Trials studying Psoriasis
172 Patients Enrolled for Psoriasis
Yolanda Helfrich, MDPrincipal InvestigatorUniversity of Michigan
2 Previous Clinical Trials
63 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant, breastfeeding, or have a history of diabetes, thyroid disease, or inflammatory bowel disease.I am 12 years old or older.You are generally healthy and in good overall condition.I have used treatments for psoriasis recently.My psoriasis is either untreated or I've been on a stable treatment for over 12 months.I have signed and someone witnessed my consent form.My psoriasis is severe enough to need stronger medication or hospital care.You have had a skin condition called drug-induced psoriasis or pustular psoriasis in the past.I am willing and able to follow the study's requirements.I have had psoriasis for at least 6 months, covering more than 2% of my body or two large areas.
Research Study Groups:
This trial has the following groups:- Group 1: Psoriasis
- Group 2: Healthy Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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