An interventional study of Open wheat challenge and Placebo challenge in Psoriasis and Gluten Sensitivity, sponsored by University of Palermo. Recruiting at 3 sites in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-12.
Sponsored by University of Palermo · Not applicable, Interventional, and Treatment
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.
Psoriasis is a systemic chronic inflammatory immune-mediated disease whose etiopathogenetic mechanisms involve genetic predisposition, as well as 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, with a typical pair distribution. However, psoriasis is far from being considered just a dermatologic condition because the cytokine's cascade [including interleukin (IL)-1β, IL-17, IL-22, IL-23, Interferon (IFN)-γ, and Tumor Necrosis Factor (TNF)-α], which lays behind its inflammatory and immune-mediated pathogenesis, can determine multiple systemic manifestations. Several reports assess that, especially in moderate-to-severe psoriasis, the same inflammatory cytokines, found in cutaneous plaques, can be found in blood, and should be considered the enhancers of a chronic inflammatory condition, which, in long-term, will flow in systemic comorbidities, such as psoriatic arthritis, cardiovascular diseases, diabetes mellitus, obesity, nonalcoholic fatty liver disease, and inflammatory bowel disease.
In addition, a variable percentage of psoriatic patients (0.2-4.3%) may present with concomitant celiac disease (CD), a well-known immune-mediated bowel disease, as well as patients suffering from CD have an increased risk of psoriasis development, and, finally, several patients with psoriasis often complains of gastrointestinal (GI) symptoms.
These evidences have recently induced authors to focus their attention over the gut-skin axis and its possible pathogenetic and immunoregulatory role in psoriasis. In this context, some studies analyzed the role of intestinal permeability and, more specifically, of the gut barrier integrity, proving that an altered gut barrier is associated with GI symptoms, systemic inflammation, and increased blood concentration of gut microbiota-derived metabolites (e.g., trimethylamine N-oxide). Confirming a strict relationship between psoriasis and gut, from a clinical point of view, several dietetic approaches (e.g., Mediterranean, low calories, protein-restricted, and vegetarian diets) have shown a certain efficacy in improve psoriasis cutaneous and systemic manifestations. Moreover, some authors showed a positive effect of a gluten-free diet (GFD) over Psoriasis Area and Severity Index (PASI) score, even if contrasting data are reported, and, to date, no large randomized controlled trials have been performed.
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, initially named as Non-Celiac Gluten Sensitivity, assuming that, as in CD, gluten was the main culprit, is characterized by both GI [irritable bowel syndrome (IBS)-like and functional dyspepsia-like] and extraintestinal (e.g., fatigue, neuropsychiatric disorders, dermatitis, gynecological alterations, etc.) symptoms, which are triggered by wheat ingestion. Moreover, an increasing number of data have shown that patients with NCWS could have an association with autoimmune diseases, including thyroiditis, Sjogren's syndrome, undifferentiated connective tissue disease, and psoriatic arthritis. Conflicting data have been reported about the underlying physiopathology and possible symptom's triggers. Some authors identified a prevalent role for fermentable oligosaccharides-disaccharides-monosaccharides and polyols (FODMAPs), other the activation of both innate and acquired immunity. More recently, it has been shown that wheat has high concentrations of wheat amylase-trypsin inhibitors (ATIs), proteins able to activate innate immunity via toll-like receptor-4 (TLR-4) on myeloid cells. Orally ingested ATIs increase intestinal inflammation by activating gut and mesenteric lymphnode myeloid cells. A possible role in this fragmented and articulated context has been attributed to alteration of intestinal permeability. It has been known for years how exposure to gliadin, both in CD and in healthy patients (albeit with reduced levels in the latter), is able to alter intestinal permeability acting on zonulin release and signaling mechanisms. When the integrity of the intestinal barrier is compromised, penetration of toxic wheat peptides into the intestinal lamina propria could be favored, determining the onset of an inflammatory response activated by local immune system through the intervention of antigen presenting cells (APC), particularly dendritic ones. Finally, both psoriatic and NCWS patients seems to have quantitative and qualitative disbalances of gut microbiota, which could influence severity and course of these diseases. However, data on this point are conflicting and this correlation is far from being unanimously accepted.
Based on the evidence of gut involvement (i.e., influence of GFD on symptoms, increased intestinal permeability, altered microbiota) in pathogenesis and clinical manifestation of psoriasis, as well as on the ability of gluten/wheat to increase intestinal permeability, altering zonulin mechanisms of regulation and signaling, and the ability of some of its components (ATIs, but not only) to activate a local inflammatory response, 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.
In the investigators' hypothesis, exposure to gluten/wheat would cause a release of zonulin, which, binding to the surface of the intestinal epithelial cells, is able to modify cell cytoskeleton and cause the loss of normal occludins function, ultimately leading to an increased intestinal monolayer permeability. This increase in permeability would result in greater exposure of the immune system cells to gluten/wheat molecules via activation of TLR-4, with an increase in the infiltration and activation of myeloid cells in the intestinal mucosa and an augmented activity of lymphnode dendritic and myeloid cells. Such local inflammatory response, associated with an increase of circulating antigens coming from the gut's modified permeability, would have systemic repercussions, with alteration of normal cytokine pattern (e.g., increase of IL-1β, IL-22, IL-23, and TNF-α) and activation of plasmacytoid dendritic cells, as well as of other innate immune cells, in the skin. This background, in predisposed patients, represents the trigger for activation of myeloid dendritic cells and macrophages, IL-12, IL-23, and TNF-α-mediated recruitment of T helper type 17 (Th17) and T cytotoxic type 17 (Tc17) lymphocytes, and production of a new cytokines pattern (mainly IL-17A, and IFN-γ), which can stimulate keratinocytes to proliferate and produce antimicrobial peptides and other proinflammatory cytokines. Such complex cytokine's pattern produced by immune cells and keratinocytes, creates a positive feedback loop, perpetuating the inflammatory response which leads to clinical manifestation of psoriasis.
Therefore, the investigators hypothesize that a wheat-free diet (WFD) can reduce the inflammatory state and ameliorate the clinical symptoms in psoriatic 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.
Overall, the project results might provide data about a possible therapeutic role of a WFD in psoriasis, improve the knowledges about the relationship between intestinal permeability and systemic inflammation in psoriasis, and reveal, at least in part, the pathogenic mechanisms underlying NCWS.
Starting from the hypothesis of an altered gut-skin axis, based on altered intestinal permeability and systemic response, the investigators aim to:
2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.
This study's planned enrollment of 82 is close to the median of 75 across 1,565 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →University of Palermo is the lead sponsor of 145 studies on the registry; 28 are open to participants now.
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Inclusion criteria of psoriasis patients
Exclusion criteria of psoriasis patients age \<18 and >65 years;
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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.)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: Start of the study (Day 0); 2 months of wheat elimination diet (Day 60).
Effect of open wheat challenge in symptoms changing of psoriasis patients as assessed by BSA
To evaluate, by an open wheat challenge, the frequency of a coexistent NCWS condition in psoriasis patients, both of the intervention group (T2int) and the control group (T3con). The following score will be used: Body Surface Area (BSA), representing the percentage of cutaneous area affected by psoriasis.
Time frame: 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
To evaluate, by an open wheat challenge, the frequency of a coexistent NCWS condition in psoriasis patients, both of the intervention group (T2int) and the control group (T3con). 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.
Time frame: 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.
To evaluate, by an open wheat challenge, the frequency of a coexistent NCWS condition in psoriasis patients, both of the intervention group (T2int) and the control group (T3con). 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.
Time frame: 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.
To evaluate, by an open wheat challenge, the frequency of a coexistent NCWS condition in psoriasis patients, both of the intervention group (T2int) and the control group (T3con).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).
Time frame: 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.
To evaluate, by an open wheat challenge, the frequency of a coexistent NCWS condition in psoriasis patients, both of the intervention group (T2int) and the control group (T3con). 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.
Time frame: Day 60; 2 weeks of open wheat challenge (Day 75).
Effect of open wheat challenge in Quality of Life (QoL) changing of psoriasis patients.
To assess the effect that an open wheat challenge determines in QoL of patients affected with psoriasis, both of the intervention (T2int) and the control group (T3con). The following score will be used: 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).
Time frame: Day 60; 2 weeks of open wheat challenge (Day 75).
Erythrocyte sedimentation rate (ESR) changing in psoriasis and NCWS patients.
Laboratory blood analysis will be performed to assess erythrocyte sedimentation rate (ESR)
Time frame: Start of the study (Day 0); 2 months of wheat elimination diet (Day 60); 2 weeks of open wheat challenge (Day 75)
C-reactive protein (CRP) changing in psoriasis and NCWS patients.
Laboratory blood analysis will be performed to assess C-reactive protein (CRP)
Time frame: Start of the study (Day 0); 2 months of wheat elimination diet (Day 60); 2 weeks of open wheat challenge (Day 75)
Complete blood count changing in psoriasis and NCWS patients.
Laboratory blood analysis will be performed to assess complete blood count
Time frame: Start of the study (Day 0); 2 months of wheat elimination diet (Day 60); 2 weeks of open wheat challenge (Day 75)
Peripheral blood ELISA analysis of inflammatory cytokines changing in psoriasis and NCWS patients.
Peripheral blood ELISA analysis of inflammatory cytokines pattern will be performed to assess: interleukin (IL)-1β
Time frame: Start of the study (Day 0); 2 months of wheat elimination diet (Day 60); 2 weeks of open wheat challenge (Day 75)
Peripheral blood ELISA analysis of inflammatory cytokines changing in psoriasis and NCWS patients.
Peripheral blood ELISA analysis of inflammatory cytokines pattern will be performed to assess: interleukin (IL)-2
Time frame: Start of the study (Day 0); 2 months of wheat elimination diet (Day 60); 2 weeks of open wheat challenge (Day 75)
Peripheral blood ELISA analysis of inflammatory cytokines changing in psoriasis and NCWS patients.
Peripheral blood ELISA analysis of inflammatory cytokines pattern will be performed to assess: interleukin (IL)-4
Time frame: Start of the study (Day 0); 2 months of wheat elimination diet (Day 60); 2 weeks of open wheat challenge (Day 75)
Peripheral blood ELISA analysis of inflammatory cytokines changing in psoriasis and NCWS patients.
Peripheral blood ELISA analysis of inflammatory cytokines pattern will be performed to assess: interleukin (IL)-5
Time frame: Start of the study (Day 0); 2 months of wheat elimination diet (Day 60); 2 weeks of open wheat challenge (Day 75)
Peripheral blood ELISA analysis of inflammatory cytokines changing in psoriasis and NCWS patients.
Peripheral blood ELISA analysis of inflammatory cytokines pattern will be performed to assess: interleukin (IL)-6
Time frame: Start of the study (Day 0); 2 months of wheat elimination diet (Day 60); 2 weeks of open wheat challenge (Day 75)
Peripheral blood ELISA analysis of inflammatory cytokines changing in psoriasis and NCWS patients.
Peripheral blood ELISA analysis of inflammatory cytokines pattern will be performed to assess: interleukin (IL)-8
Time frame: Start of the study (Day 0); 2 months of wheat elimination diet (Day 60); 2 weeks of open wheat challenge (Day 75)
Peripheral blood ELISA analysis of inflammatory cytokines changing in psoriasis and NCWS patients.
Peripheral blood ELISA analysis of inflammatory cytokines pattern will be performed to assess: interleukin (IL)-10
Time frame: Start of the study (Day 0); 2 months of wheat elimination diet (Day 60); 2 weeks of open wheat challenge (Day 75)
Peripheral blood ELISA analysis of inflammatory cytokines changing in psoriasis and NCWS patients.
Peripheral blood ELISA analysis of inflammatory cytokines pattern will be performed to assess: interleukin (IL)-17A
Time frame: Start of the study (Day 0); 2 months of wheat elimination diet (Day 60); 2 weeks of open wheat challenge (Day 75)
Peripheral blood ELISA analysis of inflammatory cytokines changing in psoriasis and NCWS patients.
Peripheral blood ELISA analysis of inflammatory cytokines pattern will be performed to assess: interleukin (IL)-22
Time frame: Start of the study (Day 0); 2 months of wheat elimination diet (Day 60); 2 weeks of open wheat challenge (Day 75)
Peripheral blood ELISA analysis of inflammatory cytokines changing in psoriasis and NCWS patients.
Peripheral blood ELISA analysis of inflammatory cytokines pattern will be performed to assess: interleukin (IL)-23,
Time frame: Start of the study (Day 0); 2 months of wheat elimination diet (Day 60); 2 weeks of open wheat challenge (Day 75)
Peripheral blood ELISA analysis of inflammatory cytokines changing in psoriasis and NCWS patients.
Peripheral blood ELISA analysis of inflammatory cytokines pattern will be performed to assess: Tumor Necrosis Factor (TNF)-α
Time frame: Start of the study (Day 0); 2 months of wheat elimination diet (Day 60); 2 weeks of open wheat challenge (Day 75)
Peripheral blood ELISA analysis of inflammatory cytokines changing in psoriasis and NCWS patients.
Peripheral blood ELISA analysis of inflammatory cytokines pattern will be performed to assess: interferon (IFN)-γ
Time frame: Start of the study (Day 0); 2 months of wheat elimination diet (Day 60); 2 weeks of open wheat challenge (Day 75)
Peripheral blood ELISA analysis of inflammatory cytokines changing in psoriasis and NCWS patients.
Peripheral blood ELISA analysis of inflammatory cytokines pattern will be performed to assess: Toll-Like Receptor (TLR)-4.
Time frame: Start of the study (Day 0); 2 months of wheat elimination diet (Day 60); 2 weeks of open wheat challenge (Day 75)
Peripheral blood cytofluorimetric analysis to evaluate expression of lymphocytes typical of psoriasis
Peripheral blood cytofluorimetric analysis will be performed to assess expression of lymphocytes typical of psoriasis pathogenetic pattern \[i.e., T helper (Th)17, and T cytotoxic (Tc)17\].
Time frame: Start of the study (Day 0); 2 months of wheat elimination diet (Day 60); 2 weeks of open wheat challenge (Day 75)
Peripheral blood ELISA analysis of intestinal permeability markers changing in psoriasis and NCWS patients.
Peripheral blood ELISA analysis of intestinal permeability markers will be performed to assess: zonulin
Time frame: Start of the study (Day 0); 2 months of wheat elimination diet (Day 60); 2 weeks of open wheat challenge (Day 75)
Peripheral blood ELISA analysis of intestinal permeability markers changing in psoriasis and NCWS patients.
Peripheral blood ELISA analysis of intestinal permeability markers will be performed to assess: F-Actin
Time frame: Start of the study (Day 0); 2 months of wheat elimination diet (Day 60); 2 weeks of open wheat challenge (Day 75)
Peripheral blood ELISA analysis of intestinal permeability markers changing in psoriasis and NCWS patients.
Peripheral blood ELISA analysis of intestinal permeability markers will be performed to assess: intestinal fatty acid-binding protein (i-FABP)
Time frame: Start of the study (Day 0); 2 months of wheat elimination diet (Day 60); 2 weeks of open wheat challenge (Day 75)
Peripheral blood ELISA analysis of intestinal permeability markers changing in psoriasis and NCWS patients.
Peripheral blood ELISA analysis of intestinal permeability markers will be performed to assess: lipopolysaccharide (LPS)
Time frame: Start of the study (Day 0); 2 months of wheat elimination diet (Day 60); 2 weeks of open wheat challenge (Day 75)
Peripheral blood ELISA analysis of intestinal permeability markers changing in psoriasis and NCWS patients.
Peripheral blood ELISA analysis of intestinal permeability markers will be performed to assess: LPS-binding protein (LBP)
Time frame: Start of the study (Day 0); 2 months of wheat elimination diet (Day 60); 2 weeks of open wheat challenge (Day 75)
Lactulose(LA)/Mannitol(MA) test changing in psoriasis and NCWS patients.
LA/MA test will be performed to assess in vivo intestinal permeability.
Time frame: Start of the study (Day 0); 2 months of wheat elimination diet (Day 60); 2 weeks of open wheat challenge (Day 75)
Fecal ELISA analysis of inflammatory gut marker changing in psoriasis and NCWS patients.
Fecal ELISA analysis of inflammatory gut marker will be performed to assess fecal calprotectin.
Time frame: Start of the study (Day 0); 2 months of wheat elimination diet (Day 60); 2 weeks of open wheat challenge (Day 75)
Gut microbiota changing in psoriasis and NCWS patients.
Gut microbiota assessment will be performed by analysis and quantification of gut microbioma on stools samples. After fecal collection, bacterial DNA will be extracted by cetyltrimethyl ammonium bromide. A simple and inexpensive physical lysis method for DNA and RNA extraction from freshwater microalgae and 16S ribosomal ribonucleic acid (rRNA) sequencing will be performed by polymerase chain reaction (PCR) methods, using universal primers. The resulting fragments will be then sequenced by pyrosequencing. Each reading will be compared with a database of known 16S rRNA sequences, using the BLAT program by phylogenetically assigning the most specific and reliable nodes. This method of assigning the obtained data leads to a "weighted" phylogenetic tree that characterizes well the bacterial content of the sample.
Time frame: Start of the study (Day 0); 2 months of wheat elimination diet (Day 60); 2 weeks of open wheat challenge (Day 75)
Plan to share: No
Ran from Jan 2025 to primary completion in Jan 2026, 12 months.
Of 115 non-industry interventional studies with no phase under Psoriasis, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 12 months is below that.
Counting every sponsor, half of 134 studies reached it within 19 months; a quarter within 8 and three quarters within 38.
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