Non Celiac Wheat SensitivityIBS (Irritable Bowel Syndrome)Functional DyspepsiaCeliac Disease
Investigational drug(s) / intervention(s)
Wheat-Free Diet
Wheat-Free Diet: Patients, identified at T1, will undergo a 6-week long strict WFD (preliminary dietician consul will be granted to all subjects), at the end of which (T2) they will fill-out an online form including a WFD adherence questionnaire (i.e. modified 'Biagi' score) and the questionnaires reported in WP1. Patients reporting a reduction ≥30% in at least one questionnaire after WFD will be identified as self-reported NCWS, all the others will be identified as IBS/FD not related to wheat intake.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria
* CD patient's relatives
* \>18 years old
* reporting IBS/FD-like and extraintestinal (EI) symptoms
Exclusion criteria
* 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;
* diagnosis of chronic inflammatory bowel disease or other organic pathologies affecting the digestive system \[e.g., IgE-mediated Wheat Allergy (WA), microscopic colitis, diverticulitis, segmental colitis associated with diverticulosis, etc.\], neurological diseases, major psychiatric disorders, infectious diseases, immunological deficiencies, and impairments limiting physical activity.
Primary outcome measure(s)
Identification of patients with self-reported NCWS or IBS/FD not related to wheat intake among relatives of CD patients: Gastrointestinal Symptom Rating Scale (GSRS) — From baseline to 6-week CD patient's relatives included in the study will refill out the following online questionnaire at the end of the 6-week long strict WFD (T2): - Gastrointestinal Symptom Rating Scale (GSRS) (range from 15 to 105) Patients reporting a reduction ≥30% in the questionnaire after WFD will be identified as patients with self-reported NCWS. Patients not reporting a reduction ≥30% in at least one questionnaire after WFD will be identified as patients with IBS/FD not related to wheat intake.
Trial sites (2)
Facility
City
Region
Status
Celiac Disease and Food Intolerance Clinic, Geriatrics Unit, "P. Giaccone" University Hospital, Palermo
Palermo
PA
Recruiting
Internal Medicine Unit, P.O. "V. Cervello," Ospedali Riuniti "Villa Sofia-Cervello," Palermo
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
