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

NCT ID: NCT01827566

Last Updated: 2014-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non Celiac Gluten Sensitivity

Keywords

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Celiac Disease Gluten Sensitivity Gluten Double-blind challenge, placebo-controlled challenge Gluten free flour

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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gluten

10 grams of gluten in each sachet to be dispersed daily on food for ten days, while maintaining a gluten free diet

Group Type ACTIVE_COMPARATOR

gluten

Intervention Type OTHER

gluten free flour

10 grams of gluten free flour in each sachet to be dispersed daily on food for ten days, while maintaining a gluten free diet

Group Type PLACEBO_COMPARATOR

gluten free flour

Intervention Type OTHER

Interventions

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gluten

Intervention Type OTHER

gluten free flour

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adherence to gluten free diet without medical need
* Negative Celiac Disease related serology (while on gluten containing diet)
* Normal villous structure at duodenal biopsy (while on gluten containing diet)

Exclusion Criteria

* Diagnosis of Celiac Disease
* Diagnosis of Wheat Allergy
* Diagnosis of organic gastrointestinal disease
* Severe concomitant disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi di Brescia

OTHER

Sponsor Role lead

Responsible Party

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Alberto Lanzini, MD PhD

Associate Professor of Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alberto Lanzini, MD, PhD

Role: STUDY_CHAIR

University of Brescia, Unit of Gastroenterology

Barbara Zanini, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Brescia, Unit of Gastroenterology

Chiara Ricci, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Brescia, Unit of Gastroenterology

Locations

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University and Spedali Civili of Brescia, Unit of Gastroenterology

Brescia, , Italy

Site Status

Countries

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Italy

Other Identifiers

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GE-2012-GS

Identifier Type: -

Identifier Source: org_study_id