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Search / Trial NCT05644782

Dietary Approach to Mild-to-moderate Psoriasis

Launched by UNIVERSITY OF PALERMO · Nov 30, 2022

Trial Information

Current as of February 05, 2025

Recruiting

Keywords

Psoriasis Gluten Sensitivity Gluten Free Diet

ClinConnect Summary

This clinical trial is exploring whether a wheat-free diet can help improve symptoms in patients with mild-to-moderate psoriasis. Psoriasis is a skin condition that causes red, scaly patches, and it can also be linked to other health issues, including gastrointestinal problems. The researchers believe that gluten, a protein found in wheat, may worsen psoriasis symptoms for some people. By removing gluten from their diet, they hope to see if participants experience less inflammation and better skin health.

To qualify for the study, participants should be adults aged 18 to 65 who haven’t received systemic treatment for their psoriasis in the last three months and have tested negative for specific antibodies related to gluten sensitivity and wheat allergy. Those who join the study will follow a wheat-free diet and will be monitored for changes in their psoriasis symptoms. Additionally, after the diet period, participants may try reintroducing wheat to see if their symptoms return, which will help the researchers understand the role gluten plays in psoriasis.

Gender

ALL

Eligibility criteria

  • Inclusion criteria of psoriasis patients
  • age \>18 and \<65 years;
  • no systemic therapy for psoriasis for at least 3 months before inclusion in the study;
  • negativity of anti-deamidated gliadin protein (anti-DGP) immunoglobulins (Ig) class A (IgA) and immunoglobulins (Ig)G, anti-tissue transglutaminase (anti-tTG) class IgA and IgG, and Endomysium antibodies (EmA);
  • absence of WA (negative prick-test and/or specific serum immunoglobulins (Ig)E assay for wheat, gluten, and gliadin).
  • Exclusion criteria of psoriasis patients age \<18 and \>65 years;
  • severe chronic plaque-type psoriasis (based on BSA);
  • self-exclusion of gluten/wheat from the diet and refusal to reintroduce it, for diagnostic purposes, before entering the study;
  • pregnancy;
  • alcohol and/or drug abuse;
  • Helicobacter pylori and other bacterial and/or parasitic infections;
  • diagnosis of chronic inflammatory bowel disease and other organic pathology affecting the digestive system (e.g., severe liver disease), nervous system diseases, major psychiatric disorders, immunological deficits, and impairments that limit physical activity;
  • diagnosis of cancer
  • treatment with steroids and/or immunological therapies;
  • patients undergoing chemotherapy and/or radiotherapy.

Trial Officials

Antonio Carroccio, MD

Study Director

University of Palermo

Maria R. Bongiorno, MD

Study Chair

University of Palermo

About University Of Palermo

The University of Palermo, a distinguished institution located in Italy, is dedicated to advancing medical research and education through innovative clinical trials. Renowned for its commitment to scientific excellence, the university leverages its multidisciplinary expertise and state-of-the-art facilities to conduct research that addresses critical healthcare challenges. By fostering collaborations with leading researchers and healthcare professionals, the University of Palermo aims to translate scientific findings into effective therapies, ultimately contributing to improved patient outcomes and public health advancements.

Locations

Palermo, , Italy

Palermo, Pa, Italy

Palermo, , Italy

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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