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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Italy
Internal Medicine Department of the University Hospital of Palermo
RECRUITING
Palermo
Internal Medicine Division of the Cervello-Villa Sofia Hospital
RECRUITING
Palermo
Rheumatology Department of the University Hospital of Palermo
RECRUITING
Palermo
Contact Information
Primary
Pasquale Mansueto, MD
pasquale.mansueto@unipa.it
+393477279879
Backup
Aurelio Seidita, MD
aurelio.seidita@unipa.it
+393209150370
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2026-01-30
Participants
Target number of participants: 30
Treatments
Active_comparator: Active Comparator: wheat/milk free diet (W/MFD) group
Patients randomized to intervention group will go to a 2 months elimination diet (wheat and cow's milk products). After 2 months of elimination diet they will go to an open challenge, with reintroduction of wheat. After 2 weeks of open diet or whenever rheumatologic, intestinal and/or extraintestinal symptoms should return or intensify, patients will end the study.
Placebo_comparator: Placebo Comparator: rice/turkey free diet (R/TFD) group
Patients randomized to control group will go to a 2 months elimination diet (rice and turkey's meat). After 2 months of elimination diet they will crossover to a 2 months elimination diet (wheat and cow's milk products). After 2 months of elimination diet they will go to an open challenge, with reintroduction of wheat. After 2 weeks of open diet or whenever rheumatologic, intestinal and/or extraintestinal symptoms should return or intensify, patients will end the study.
Sponsors
Leads: University of Palermo
Collaborators: Aurelio Seidita

This content was sourced from clinicaltrials.gov