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

NARecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

January 1, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

January 30, 2026

Conditions
Sjogren's SyndromeNon-celiac Gluten Sensitivity
Interventions
DIETARY_SUPPLEMENT

Wheat/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_SUPPLEMENT

Rice/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.

Trial Locations (3)

90127

RECRUITING

Internal Medicine Department of the University Hospital of Palermo, Palermo

RECRUITING

Rheumatology Department of the University Hospital of Palermo, Palermo

90146

RECRUITING

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

All Listed Sponsors
collaborator

Aurelio Seidita

UNKNOWN

lead

University of Palermo

OTHER