82
Participants
Start Date
January 1, 2023
Primary Completion Date
July 30, 2024
Study Completion Date
October 31, 2025
Open wheat 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.
Placebo challenge
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.
RECRUITING
Dermatology Department of the University Hospital 'P. Giaccone' of Palermo, Italy,, Palermo
RECRUITING
Internal Medicine Department of the University Hospital of Palermo, Palermo
RECRUITING
"Internal Medicine Division of the Cervello-Villa Sofia Hospital", Palermo
Aurelio Seidita
UNKNOWN
University of Palermo
OTHER