Dietary Approach to Mild-to-moderate Psoriasis

NCT05644782 | Recruiting

• 1 other identifier: ACPM30
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 3

Brief Summary

Psoriasis is a systemic chronic inflammatory immune-mediated disease whose etiopathogenetic mechanisms involve genetic predisposition, and immunological and environmental factors. Its prevalence is about 3% in adults, and it is characterized by well-demarcated, erythematous plaques, covered by silvery-white scales, in elbows, knees, trunk, and scalp. However, psoriasis is far from being considered just a dermatologic condition because the cytokine's cascade, which lays behind its inflammatory and immune-mediated pathogenesis, can determine multiple systemic manifestations. In addition, several patients with psoriasis often complains of gastrointestinal (GI) symptoms. Therefore, authors focused their attention over the gut-skin axis and its possible pathogenetic and immunoregulatory role in psoriasis (i.e., altered gut barrier, increased blood concentration of gut microbiota-derived metabolites, systemic inflammation). In this context, several dietetic approaches (e.g., Mediterranean, low calories, protein-restricted, vegetarian diets, and gluten-free diet, GFD) have shown a certain efficacy in improve psoriasis cutaneous and systemic manifestations. In recent years, the existence of a wheat-related disorder in patients who do not suffer from CD or wheat allergy (WA) has been definitively ascertained and defined as Non-Celiac Wheat Sensitivity (NCWS). Its prevalence in the general population is unknown, but self-reported NCWS is around 10%. This condition is characterized by both GI and extraintestinal symptoms, which are triggered by wheat ingestion. In these patients, wheat ingestion might lead to alteration in intestinal permeability and gut microbiota and to systemic immune activation and inflammation. Based on the evidence of gut involvement in the pathogenesis and clinical manifestation of psoriasis, as well as on the ability of gluten/wheat to increase intestinal permeability, it could be hypothesized that gluten/wheat may represents one of the pathogenetic environmental factors of psoriasis and that its intake may be able to worsen symptoms in affected patients. The investigators hypothesize that a wheat-free diet (WFD) can reduce the inflammatory state and ameliorate the clinical symptoms in psoriasis patients. The successive clinical and immunologic reaction to the re-exposure to wheat ingestion, performed by an open challenge, will be also evaluated to confirm a wheat-dependent mechanism and to understand the underlining physiopathology.

Conditions

Psoriasis; Gluten Sensitivity

Keywords

psoriasis; gluten sensitivity; gluten-free diet

Outcome Measures

Primary Outcomes (7)

• Self-perceived non-celiac wheat sensitivity (NCWS) questionnaire in psoriasis patients

  To identify psoriasis patients reporting a self-perceived NCWS; all patients will be asked to answer, consecutively, to a validated questionnaire for the self-assessment of wheat and other foods' intolerance. This is a questionnaire self-compiled by patients consisting of three sections: 1) general information (eg. age, sex, highest completed education level, etc.) 2) wheat-related symptoms (sore 0 = no symptoms, score = 1, symptoms after wheat intake; if score = 1 other question qualitatively inquire the symptoms evoked by wheat intake, eg. what kind of symptoms, how long patient perceive this problem, etc.); 3) other foods-related symptoms (score 0 = no symptoms, score 1 = symptoms after intake of other foods; if score = 1 other question qualitatively inquire the symptoms evoked by the intake of the specific food reported by the patients, eg. what kind of symptoms, how long patient perceive this problem, etc.)

  Before enter the study.

• Effect of WFD plus CMPFD in changing symptoms of psoriasis patients as assessed by BSA

  To assess the effect that a WFD plus CMPFD determines in symptoms of patients affected with psoriasis the following score will be used: Body Surface Area (BSA), representing the percentage of cutaneous area affected by psoriasis.

  Start of the study (Day 0); 2 months of wheat elimination diet (Day 60).

• Effect of WFD plus CMPFD in changing symptoms of psoriasis patients as assessed by Psoriasis Area Severity Index

  To assess the effect that a WFD plus CMPFD determines in symptoms of patients affected with psoriasis the following score will be used: Psoriasis Area Severity Index (PASI), a composite evaluation for psoriasis severity, subscoring for erythema, induration, scaling, and percentage of body-surface area affected. The rating scale includes 4 levels: No Psoriasis, Mild Psoriasis, Moderate Psoriasis, and Severe Psoriasis.

  Start of the study (Day 0); 2 months of wheat elimination diet (Day 60).

• Effect of WFD plus CMPFD in changing symptoms of psoriasis patients as assessed by IGA

  To assess the effect that a WFD plus CMPFD determines in symptoms of patients affected with psoriasis the following score will be used: Investigator's Global Assessment (IGA), a 5-point instrument for rating the clinician's impression of the overall severity of the psoriasis, from 0, clear skin, to 4, severe disease.

  Start of the study (Day 0); 2 months of wheat elimination diet (Day 60).

• Effect of WFD plus CMPFD in changing symptoms of psoriasis patients as assessed by GSRS

  To assess the effect that a WFD plus CMPFD determines in symptoms of patients affected with psoriasis the following score will be used: Gastrointestinal Symptom Rating Scale (GSRS), assessment scale for irritable bowel syndrome-like and functional dyspepsia-like symptoms, providing for a score ranging from 15 to 60).

  Start of the study (Day 0); 2 months of wheat elimination diet (Day 60).

• Effect of WFD plus CMPFD in changing symptoms of psoriasis patients as assessed by Extraintestinal symptoms rating scale.

  To assess the effect that a WFD plus CMPFD determines in symptoms of patients affected with psoriasis the following score will be used: Extraintestinal symptoms rating scale, a scoring system based on the symptoms most frequently observed in NCWS patients, providing for a score ranging from 9 to 34.

  Start of the study (Day 0); 2 months of wheat elimination diet (Day 60).

• Effect of WFD plus CMPFD in changing Quality of Life (QoL) of psoriasis patients.

  To assess the effect that a WFD plus CMPFD determines in QoL of patients affected with psoriasis, both of the intervention and the control group. The following score will be used: Dermatology Life Quality Index (DLQI, a validated instrument to evaluate quality of life for skin disease, providing for a score ranging from 0 to 30 points, with higher scores indicating a greater effect on quality of life).

  Start of the study (Day 0); 2 months of wheat elimination diet (Day 60).

Secondary Outcomes (31)

• Effect of open wheat challenge in symptoms changing of psoriasis patients as assessed by BSA

  Day 60; 2 weeks of open wheat challenge (Day 75).

• Effect of open wheat challenge in symptoms changing of psoriasis patients as assessed by Psoriasis Area Severity Index

  Day 60; 2 weeks of open wheat challenge (Day 75).

• Effect of open wheat challenge in symptoms changing of psoriasis patients as assessed by IGA.

  Day 60; 2 weeks of open wheat challenge (Day 75).

• Effect of open wheat challenge in symptoms changing of psoriasis patients as assessed by GSRS.

  Day 60; 2 weeks of open wheat challenge (Day 75).

• Effect of open wheat challenge in symptoms changing of psoriasis patients as assessed by Extraintestinal symptoms rating scale.

  Day 60; 2 weeks of open wheat challenge (Day 75).

Study Arms (2)

Open wheat challenge group

ACTIVE COMPARATOR

Before starting the elimination diet (time 0, T0), intervention patients will be evaluated by experienced dermatologists, as well as by physicians with expertise in the field of food intolerance about GI and extraintestinal symptoms related to foods intake. Moreover, all these subjects will be subjected to blood, urine, and stools collections, and to a dietary consult, and a food and symptom's diary will be provided to all patients, which must be filled-in daily. After 2 months of elimination diet (time 1, T1), intervention patients will be evaluated again both clinically and by laboratory techniques, identically to T0. At this time-point, intervention patients will go to an open challenge, with reintroduction of wheat. After 2 weeks of open diet or whenever dermatologic, intestinal and/or extraintestinal symptoms should return or intensify (T2int), patients will be valued again both clinically and by laboratory techniques, identically to T0 and T1, and then will end the study.

Other: Open wheat challenge

Placebo group

PLACEBO COMPARATOR

Before starting the elimination diet (time 0, T0), control patients will be evaluated by experienced dermatologists, as well as by physicians with expertise in food intolerance. Moreover, patients will be subjected to blood, urine, and stools collections, and to a dietary consult, and a food and symptom's diary will be provided. After 2 months of elimination diet (time 1, T1), patients will be evaluated, identically to T0. Then, control patients will be asked to repeat the elimination diet, this time removing wheat and all cow's milk products for further 2 months (T2con). Then, patients will be valued again both clinically and by laboratory techniques, identically to T0 and T1. Then, patients will go to an open challenge, with reintroduction of wheat. After 2 weeks of open diet or whenever dermatologic, intestinal and/or extraintestinal symptoms should return or intensify (T3con), patients will be valued again, identically to T0, T1 and T2con, and then will end the study.

Other: Placebo challenge

Interventions

Open wheat challenge OTHER

Patients randomized to intervention diet group will have to follow a diet with elimination of wheat and cow's milk products for 2 months; after that they will be exposed to an open wheat challenge, with reintroduction of wheat. After 2 weeks of open diet, or whenever dermatologic, intestinal and/or extraintestinal symptoms should return or intensify, all patients will be revaluated and will end the study.

Also known as: Wheat

Open wheat challenge group

Placebo challenge OTHER

Patients randomized to control diet group will have to follow a diet with elimination of rice and turkey's meat products for 2 months; after that they will crossover to a wheat and cow's milk products free diet and, finally, after 2 months, they will be exposed to an open wheat challenge, with reintroduction of wheat. After 2 weeks of open diet, or whenever dermatologic, intestinal and/or extraintestinal symptoms should return or intensify, all patients will be revaluated and will end the study.

Also known as: Placebo

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \>18 and \<65 years;
• 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).

You may not qualify if:

• severe chronic plaque-type psoriasis (based on BSA);
• 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.

Sponsors & Collaborators

• University of Palermo: lead
• Aurelio Seidita: collaborator

Study Sites (3)

Dermatology Department of the University Hospital 'P. Giaccone' of Palermo, Italy,

Palermo, Palermo, 90127, Italy

RECRUITING

Internal Medicine Department of the University Hospital of Palermo

Palermo, Palermo, 90127, Italy

RECRUITING

Internal Medicine Division of the "Cervello-Villa Sofia" Hospital

Palermo, PA, 90146, Italy

RECRUITING

Related Publications (5)

• Marsili F, Travaglini M, Stinco G, Manzoni R, Tiberio R, Prignano F, Mazzotta A, Cannavo SP, Cuccia A, Germino M, Bongiorno MR, Persechino S, Florio T, Pettinato M, Tabanelli M, Sarkar R, Aloisi E, Bartezaghi M, Orsenigo R. Effectiveness of cyclosporine A in patients with moderate to severe plaque psoriasis in a real-life clinical setting in Italy: the TRANSITION study. J Dermatolog Treat. 2022 Feb;33(1):401-407. doi: 10.1080/09546634.2020.1757017. Epub 2020 Apr 30.

  PMID: 32349568 RESULT

• Pistone G, Gurreri R, Tilotta G, Caruso P, Curiale S, Bongiorno MR. Timing of quality of life improvements in psoriatic patients treated with different systemic therapies. Dermatol Ther. 2019 Sep;32(5):e13021. doi: 10.1111/dth.13021. Epub 2019 Jul 31.

  PMID: 31306540 RESULT

• Carroccio A, Giambalvo O, Blasca F, Iacobucci R, D'Alcamo A, Mansueto P. Self-Reported Non-Celiac Wheat Sensitivity in High School Students: Demographic and Clinical Characteristics. Nutrients. 2017 Jul 19;9(7):771. doi: 10.3390/nu9070771.

  PMID: 28753927 RESULT

• Carroccio A, Rini G, Mansueto P. Non-celiac wheat sensitivity is a more appropriate label than non-celiac gluten sensitivity. Gastroenterology. 2014 Jan;146(1):320-1. doi: 10.1053/j.gastro.2013.08.061. Epub 2013 Nov 22. No abstract available.

  PMID: 24275240 RESULT

• Carroccio A, Mansueto P, Iacono G, Soresi M, D'Alcamo A, Cavataio F, Brusca I, Florena AM, Ambrosiano G, Seidita A, Pirrone G, Rini GB. Non-celiac wheat sensitivity diagnosed by double-blind placebo-controlled challenge: exploring a new clinical entity. Am J Gastroenterol. 2012 Dec;107(12):1898-906; quiz 1907. doi: 10.1038/ajg.2012.236. Epub 2012 Jul 24.

  PMID: 22825366 RESULT

MeSH Terms

Conditions

Psoriasis; Celiac Disease

Interventions

Flour

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Antonio Carroccio, MD

  University of Palermo

  STUDY DIRECTOR

• Maria R. Bongiorno, MD

  University of Palermo

  STUDY CHAIR

Central Study Contacts

Pasquale Mansueto, MD

CONTACT

+393477279879; pasquale.mansueto@unipa.it

Aurelio Seidita, MD

CONTACT

+393209150370; aurelio.seidita@unipa.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, randomized, placebo-controlled, cross-over, single center clinical trials.

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: December 9, 2022
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)