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Symptomatic Response to Gluten Challenge in Patients With Suspected Non Celiac Gluten Sensitivity

NCT01864993 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2016-02-24

No results posted yet for this study

Summary

Non Celiac Gluten Sensitivity (NCGS) is an emergent syndrome mainly inducing gastrointestinal symptoms. NCGS is suspected to be present in the 6% of the population and thus it represents an important issue in health care. Actually it remains difficult to diagnose and prove due to the lack of established criteria. The investigators intention is to establish a diagnostic flowchart to evaluate the real impact of NCGS in a cohort of patients suffering from functional gastrointestinal symptoms.

Conditions

  • Non Celiac Gluten Sensitivity

Interventions

DIETARY_SUPPLEMENT

gluten

The enrolled patients will be invited to follow a gluten free diet. Patients responsive to the diet will be invited to assume gluten or placebo following a double blind with cross over scheme

DIETARY_SUPPLEMENT

Placebo

Patients responsive to the diet will be invited to blindly assume gluten or placebo following a double blind with cross over scheme

Sponsors & Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    lead OTHER

Principal Investigators

  • Luca Elli, MD, PhD · Center for Prevention and Diagnosis of Celiac Disease, Fondazione IRCCS Cà Granda

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2016-02-29
Completion
2016-02-29

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 NCT01864993 on ClinicalTrials.gov