Liver Steatosis and Fibrosis in Non-Celiac Wheat Sensitivity Patients: a Prospective Study

Sponsor
University of Palermo
Study ID
NCT07750535
Status
Recruiting
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Conditions

  • Celiac Disease
  • Functional Dyspepsia
  • Irritable Bowel Syndrome
  • Metabolic Dysfunction-Associated Steatotic Liver Disease
  • Non Celiac Wheat Sensitivity

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Prevalence and severity of liver steatosis and fibrosis, — DIAGNOSTIC_TEST
    To establish the prevalence and severity of liver steatosis and fibrosis, the researchers will analyze data from the UltraSound (US) and FibroScan examinations, and from two validate scores performed before diagnosis.

Study Details

Hypothesizing an intestinal barrier impairment as a common pathophysiological substrate of both Non Celiac Wheat Sensitivity (NCWS) and Metabolic Dysfunction-Associated Steatotic Liver Disease (MAFLD), in a retrospective cohort study (data not yet published), demographic, clinical, laboratory and histology data of NCWS patients at the time of diagnosis, were analyzed and compared to control subjects with Irritable Bowel Syndrome/Functional Dyspepsia (IBS/FD) and freshly diagnosed Celiac Disease (CeD). NCWS diagnosis was performed by a double-blind placebo-controlled wheat challenge. Steatosis was confirmed by ultrasound examination. Our retrospective data showed that the frequency of liver of steatosis was lower in NCWS than in IBS patients. In addition, it seems that pre-diagnosis avoidance of wheat in NCWS correlates with protection from steatosis. A subset of NCWS patients, recently exposed to wheat, with clinical features suggesting increased IP, seems to be predisposed to liver steatosis and fibrosis. To validate the results of the retrospective study, the researchers planned the present prospective study, to analyze the prevalence of liver steatosis and fibrosis, evaluated by ultrasound (US) examination, FibroScan analysis \[CAP (Controlled Attenuation Parameter) and LSM (Liver Stiffness Measurement) values\], FIB-4 (Fibrosis-4) index, and NFS \[Non-alcoholic fatty liver disease (NAFLD) Fibrosis Score\], in patients with NCWS at the time of diagnosis, comparing them with two control populations of newly diagnosed IBS/FD and CeD patients.

Key Dates

First listed
Aug 6, 2026
Start date
Jan 1, 2024
Status verified
Aug 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
250 participants (estimated)

Arms

  • Arm: Non-Celiac Wheat Sensitivity (NCWS) patients
    Non-Celiac Wheat Sensitivity (NCWS) patients, consecutively diagnosed by double-blind placebo-controlled challenge (DBPCC) with wheat
  • Arm: Irritable Bowel Syndrome/Functional Dyspepsia (IBS/FD) patients unrelated to food allergies
    Control population of Irritable Bowel Syndrome/Functional Dyspepsia (IBS/FD) patients unrelated to food (including wheat) allergies/intolerances
  • Arm: Celiac Disease (CeD) patients
    Control populations of Celiac Disease (CeD) patients

Primary Outcome Measure

Prevalence and severity of liver steatosis and fibrosis by Ultrasound examination [ Time Frame: At baseline, before diagnosis ]

Central Contacts

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