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Osteoporosis In Non-Celiac Wheat Sensitivity Patients

NCT02421783 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 270

Last updated 2019-09-03

No results posted yet for this study

Summary

Non-celiac gluten sensitivity (NCGS) or 'wheat sensitivity' (NCWS) is included in the spectrum of gluten-related disorders. No data are available on the prevalence of low bone mass density (BMD) in NCWS. Our study aims to evaluate the prevalence of low BMD in NCWS patients and search for correlations with other clinical characteristics.

This prospective observation study will include 90 NCWS patients with irritable bowel syndrome (IBS)-like symptoms, 90 IBS and 90 celiac controls. Patients will be recruited at the Internal Medicine and at the Gastroenterology Units of the University of Palermo. Elimination diet and double-blind placebo controlled (DBPC) wheat challenge proved the NCWS diagnosis. All subjects underwent BMD assessment by Dual Energy X-Ray Absorptiometry (DXA), duodenal histology, Human Leukocyte Antigen (HLA) DQ typing, body mass index (BMI) evaluation and assessment for daily calcium intake.

Conditions

  • Non-celiac Wheat Sensitivity

Sponsors & Collaborators

  • University of Palermo

    lead OTHER

Principal Investigators

  • Antonio Carroccio, PhD · Department of Internal Medicine, Giovanni Paolo II Hospital, Via Pompei, Sciacca, Italy

Eligibility

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

Timeline & Regulatory

Start
2015-05-01
Primary Completion
2016-10-01
Completion
2019-06-01

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 NCT02421783 on ClinicalTrials.gov