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Prevalence of Non Celiac Gluten Sensitivity Among Patients Spontaneously Adherent to Gluten Free Diet

NCT01827566 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2014-12-08

No results posted yet for this study

Summary

The purpose of this study is to assess the prevalence of Gluten Sensitivity, by a double-blind placebo-controlled challenge with gluten, followed by two months period of Low-FODMAPs (Fermentable Oligosaccharides Disaccharides Monosaccharides And Polyols) diet, in patients spontaneously adherent to gluten free diet because of symptoms upon gluten exposure and in whom diagnosis of Celiac Disease and Wheat Allergy has been ruled out.

Conditions

  • Non Celiac Gluten Sensitivity

Interventions

OTHER

gluten

OTHER

gluten free flour

Sponsors & Collaborators

  • Università degli Studi di Brescia

    lead OTHER

Principal Investigators

  • Alberto Lanzini, MD, PhD · University of Brescia, Unit of Gastroenterology

  • Barbara Zanini, MD, PhD · University of Brescia, Unit of Gastroenterology

  • Chiara Ricci, MD, PhD · University of Brescia, Unit of Gastroenterology

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2013-03-31

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 NCT01827566 on ClinicalTrials.gov