NCWS or IBS/FD in Relatives of CD Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Palermo

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Wheat-Free Diet

    Other intervention

    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.

Treatment groups

600 Participants
are divided into 1 treatment group
Group A: Six-week long strict Wheat-Free DietActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

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.

Time frame
From baseline to 6-week

Secondary outcomes

Other outcomes

1

Identification of patients with self-reported NCWS or IBS/FD not related to wheat intake among relatives of CD patients: Bristol Stool Scale

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): \- Bristol Stool Scale (from type 1, separate hard lumps, like nuts, to type 7, watery, no solid pieces, entirely liquid) 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.

Time frame
From baseline to 6-week
2

Identification of patients with self-reported NCWS or IBS/FD not related to wheat intake among relatives of CD patients: IBS-Symptom Severity Scale (IBS-SSS)

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): \- IBS-Symptom Severity Scale (IBS-SSS) (range from less than 75 to 300 or greater) 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.

Time frame
From baseline to 6-week
3

Identification of patients with self-reported NCWS or IBS/FD not related to wheat intake among relatives of CD patients: Extraintestinal Symptom Rating Scale (ESRS)

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): \- Extraintestinal Symptom Rating Scale (ESRS) (range 0 to 24 for women, and 0 to 22 for men) 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.

Time frame
From baseline to 6-week
4

Identification of patients with self-reported NCWS or IBS/FD not related to wheat intake among relatives of CD patients: IBS-Quality of Life (IBS-QoL)

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): \- IBS-Quality of Life (IBS-QoL) (range from 0 to 100). 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.

Time frame
From baseline to 6-week

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