CompletedNot Applicable

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

Italy30 participantsStarted 2023-01-01

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

The study will be a prospective, randomized, placebo-controlled, single center clinical trials. Patients diagnosed with SS, fulfilling the American-European Consensus Group criteria for SS, will be recruited at the outpatient clinic of the Rheumatology Department, University Hospital 'P. Giaccone' of Palermo, Italy. Inclusion criteria of SS patients * 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 intestinal villous atrophy, documented in all the patients carrying the DQ2 and/or the DQ8 Human Leukocyte Antigen (HLA) haplotypes (thus irrespective of CD-specific serum antibody negativity * absence of WA (negative prick-test and/or specific serum immunoglobulin (Ig) E assay for wheat, gluten, and gliadin). Exclusion criteria of SS patients * age \<18 and \>65 years; * 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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Before enter the study

Effect of WFD plus CMPFD in symptoms of SS patients as assessed by ESSPRI

Timeframe: From the start of the study (T0) to 2 months of wheat elimination diet (T1).

Effect of WFD plus CMPFD in symptoms of SS patients as assessed by ESSDAI

Timeframe: From the start of the study (T0) to 2 months of wheat elimination diet (T1).

Effect of WFD plus CMPFD in symptoms of SS patients as assessed by GSRS

Timeframe: From the start of the study (T0) to 2 months of wheat elimination diet (T1).

Effect of WFD plus CMPFD in symptoms of SS patients as assessed by Extraintestinal symptoms rating scale.

Timeframe: From the start of the study (T0) to 2 months of wheat elimination diet (T1).

Trial details

NCT IDNCT05644795

SponsorUniversity of Palermo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Sjogren's Syndrome trials