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Non-Celiac Wheat Sensitivity: Permanent or Transient Condition?

NCT02823522 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 280

Last updated 2026-05-05

No results posted yet for this study

Summary

Non-Celiac Gluten Sensitivity (NCGS) has been recently included among the gluten-related diseases. Patients suffering from NCGS are diagnosed after carefully excluding celiac disease (CD), and immunoglobulin E (IgE)-mediated wheat allergy. Then, in the absence of sensitive and specific diagnostic biomarkers for NCGS, a monitoring of the patient during elimination and re-introduction of wheat by a double-blind placebo controlled (DBPC) challenge method has been suggested as diagnostic hallmark. Some studies seem to suggest that wheat components other than gluten can cause the symptoms, and therefore the term "non-celiac wheat sensitivity" (NCWS) has been proposed instead of NCGS. While it is well known that CD is a long-life condition and a strict adherence to the gluten-free diet must be maintained, it is unknown whether this is valid for NCWS. On the year 2012, the researchers published a retrospective study, including 276 patients with irritable bowel syndrome (IBS)-like symptoms who had been diagnosed with NCWS using a DBPC challenge during a ten-years period (2001-2011). The present prospective study aimed to evaluate: A) how many of these patients are still following a wheat-free diet, and B) which percentage was still suffering from NCWS, diagnosed by DBPC wheat challenge, in a subgroup of that cohort.

Conditions

  • Non-Celiac Wheat Sensitivity

Interventions

OTHER

Patients recruitment

Between July and November 2016, the patients included in the previous retrospective study were contacted by phone, mail and e-mail and invited to come back to the respective clinics where they had been initially diagnosed as NCWS patients: the Department of Internal Medicine of the University Hospital of Palermo and the Department of Internal Medicine of the Hospital of Sciacca (province of Agrigento).

Sponsors & Collaborators

  • University of Palermo

    lead OTHER

Principal Investigators

  • Antonio Carroccio, MD · Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2024-08-31
Completion
2025-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02823522 on ClinicalTrials.gov