About this trial

Over 50% of non-celiac wheat sensitivity (NCWS) patients are HLA DQ2/DQ8 positive and often have a Celiac Disease (CD) family history. Studies have identified a subgroup of NCWS patients whose clinical and immunological features are closer to CD than to irritable bowel syndrome/functional dyspepsia (IBS/FD) ('inflammatory subgroup'). The investigators hypothesized that among CD patient's relatives, there might be a high number of NCWS subjects, who hypothetically belong to the 'inflammatory subgroup'. Therefore, the aim of this multi-step project is to identify the prevalence of both self-reported NCWS and IBS/FD not related to wheat ingestion among CD patient's relatives (parents, grandparents, siblings and sons).

Eligibility criteria

Qualifiers

CD patient's relatives

>18 years old

reporting IBS/FD-like and extraintestinal (EI) symptoms

Disqualifiers

self-exclusion of wheat from the diet and refuse to reintroduce it for diagnostic purposes;

drug and/or alcohol (>30 g/day for men and >20 g/day for women) abuse;

treatment with steroids and/or non-steroidal anti-inflammatory drugs in the 2 weeks before duodenal biopsy;

pregnancy or breastfeeding;

Trial design

Treatments tested in this trial

  • Wheat-Free Diet

Treatment groups

600 Participants
are divided into 1 treatment group

Locations

2
Celiac Disease and Food Intolerance Clinic, Geriatrics Unit, "P. Giaccone" University Hospital, Palermo90127, PalermoPA, Italy
Internal Medicine Unit, P.O. "V. Cervello," Ospedali Riuniti "Villa Sofia-Cervello," Palermo90146, PalermoPA, Italy

Sponsors and collaborators

University of Palermo

Lead sponsor