Effect of Gluten Free Diet in Patients With Burning Mouth Syndrome

NCT ID: NCT01867151

Last Updated: 2013-06-03

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-03-31

Brief Summary

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Gluten free diet (GFD) is now being tested in patients affected by schizophrenia, autism and multiple sclerosis, making GFD a possible therapeutic weapon not only for celiac disease or gluten sensitivity. In this protocol we investigate the effect of GFD in patients affected by burning mouth syndrome (BMS), a disease of unknown origin characterized by oral and especially tongue burning sensation, deeply decreasing the quality of life of patients

Detailed Description

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Conditions

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Burning Mouth Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gluten free diet

BMS patients following a GFD

Group Type EXPERIMENTAL

Gluten Free Diet

Intervention Type DIETARY_SUPPLEMENT

Normal Diet

Patients with BMS maintaing a normal diet

Group Type SHAM_COMPARATOR

Normal Diet

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Gluten Free Diet

Intervention Type DIETARY_SUPPLEMENT

Normal Diet

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

-Primary BMS

Exclusion Criteria

* Celiac Disease
* Psychiatric Disorders
* intestinal autoimmune diseases
* Ongoing cancer
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role lead

Responsible Party

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Prof. Pier Mannuccio Mannucci

Scientific Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luca Elli, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Cà Granda

Locations

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Fondazione IRCCS Ca' Granda

Milan, Italy, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Luca Elli, MD

Role: CONTACT

00390255033384

Other Identifiers

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BMS2013

Identifier Type: -

Identifier Source: org_study_id

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