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12-week Elimination Diet for Psoriasis

N/A
Recruiting
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
Male or female subjects, 12 years of age or older
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study 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 below
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I am 12 years old or older.
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My psoriasis is either untreated or I've been on a stable treatment for over 12 months.
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I have signed and someone witnessed my consent form.
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I am willing and able to follow the study's requirements.
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I have had psoriasis for at least 6 months, covering more than 2% of my body or two large areas.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

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 more
Secondary 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 more

Trial 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
1,794 Previous Clinical Trials
6,373,846 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

12-week elimination diet Clinical Trial Eligibility Overview. Trial Name: NCT03084146 — N/A
Psoriasis Research Study Groups: Psoriasis, Healthy Control
Psoriasis Clinical Trial 2023: 12-week elimination diet Highlights & Side Effects. Trial Name: NCT03084146 — N/A
12-week elimination diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT03084146 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants is the current research accommodating?

"Indeed, clinicaltrials.gov reports that this medical experiment is actively recruiting participants. Initially posted on August 28th 2017 and last updated on May 18th 2022, the trial requires 70 individuals from a single location to participate."

Answered by AI

Are there still vacancies available in this clinical testing program?

"According to the information hosted on clinicaltrials.gov, this medical study is currently recruiting participants. The trial was first advertised on August 28th 2017 and recently updated on May 18th 2022."

Answered by AI

What is the hoped-for result of this medical experiment?

"This 12-week study will monitor IgG4 Antibodies in Psoriasis patients. Additional objectives include assessing IgE antibodies, Anti-Tissue Transglutaminase (tTG) IgA and Anti-Deamidated Gliadin Peptide (DGP) IgA levels in those who underwent an elimination diet intervention."

Answered by AI

Who else is applying?

What state do they live in?
New York
Michigan
How old are they?
18 - 65
What site did they apply to?
University of Michigan Department of Dermatology
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. University of Michigan Department of Dermatology: < 24 hours
Average response time
  • < 1 Day
~1 spots leftby Jun 2024