NCWS or IBS/FD in Relatives of CD Patients

Sponsor
University of Palermo
Study ID
NCT07584473
Status
Recruiting
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Conditions

  • Celiac Disease
  • Functional Dyspepsia
  • IBS (Irritable Bowel Syndrome)
  • Non Celiac Wheat Sensitivity

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Wheat-Free Diet — OTHER
    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 Details

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).

Key Dates

Start date
Apr 1, 2026
Status verified
May 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
600 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Six-week long strict Wheat-Free Diet
    CD patient's first-degree relatives with IBS/FD-like and extraintestinal (EI) symptoms

Primary Outcome Measure

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) [ Time Frame: From baseline to 6-week ]

Central Contacts

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