RecruitingNot ApplicableNCT05644795

Wheat-free Diet in the Treatment of Sjogren's Syndrome

Efficacy of a Wheat-free Diet in Autoimmune Diseases: a Pilot Therapeutic Study in Sjogren's Disease

Sponsor

University of Palermo

Enrollment

30 participants

Start Date

Jan 1, 2023

Study Type

INTERVENTIONAL

Conditions

Sjogren's Syndrome Non-celiac Gluten Sensitivity

Summary

Recent data show that some foods can increase intestinal mucosa permeability and immune activation of subjects with gastrointestinal (GI) symptoms. Wheat seems the most frequent food which activates this inflammatory response and can cause both GI and extra-intestinal symptoms. Patients suffering from wheat-related troubles, in absence of celiac disease diagnosis, can suffer from non-celiac wheat sensitivity (NCWS) and our previous studies showed that about 25% of them are also affected by autoimmune diseases (AD). A gluten-free diet (GFD) can influence inflammatory pattern of AD, including Sjogren's syndrome (SS). Thus, the investigators would enquire if SS patients may also suffer from NCWS and how a wheat-free diet (WFD) modifies their clinical features, and inflammatory and cytokine pattern. The investigators will also assess how wheat reintroduction, by an open challenge, modifies their clinical parameters, intestinal permeability, and both local and systemic inflammatory response.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether removing wheat from the diet can reduce symptoms of Sjögren's syndrome — an autoimmune condition that mainly affects the glands that produce saliva and tears — in patients who do not have celiac disease but may have sensitivity to wheat. **You may be eligible if...** - You are between 18 and 65 years old - You have a confirmed diagnosis of Sjögren's syndrome - You test negative for celiac disease antibodies - You do not have intestinal damage (villous atrophy), even if you carry certain genetic markers (HLA DQ2/DQ8) **You may NOT be eligible if...** - You have confirmed celiac disease - You are already following a wheat-free or gluten-free diet - You have other conditions that could interfere with the study - You are outside the age range Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTWheat/milk free diet (W/MFD) group

Patients randomized to intervention diet group will have to follow a wheat and cow's milk products free diet and, 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.

DIETARY_SUPPLEMENTRice/turkey free diet (R/TFD) group

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.