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Effect of Gluten Free Diet in Patients With Burning Mouth Syndrome

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2013 by Prof. Pier Mannuccio Mannucci, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01867151
First Posted: June 3, 2013
Last Update Posted: June 3, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Prof. Pier Mannuccio Mannucci, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
  Purpose
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

Condition Intervention
Burning Mouth Syndrome Dietary Supplement: Gluten Free Diet Dietary Supplement: Normal Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effetto Della Dieta Priva di Glutine in Soggetti Con BMS

Resource links provided by NLM:


Further study details as provided by Prof. Pier Mannuccio Mannucci, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:

Primary Outcome Measures:
  • oral pain [ Time Frame: 28 days ]
    oral pain will be evaluated by means of visual analogue scales


Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 28 days ]
    quality of life of patients with BMS will be evaluated by means of SF36 questionnaire


Estimated Enrollment: 40
Study Start Date: May 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gluten free diet
BMS patients following a GFD
Dietary Supplement: Gluten Free Diet
Sham Comparator: Normal Diet
Patients with BMS maintaing a normal diet
Dietary Supplement: Normal Diet

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-Primary BMS

Exclusion Criteria:

  • Celiac Disease
  • Psychiatric Disorders
  • intestinal autoimmune diseases
  • Ongoing cancer
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01867151


Contacts
Contact: Luca Elli, MD 00390255033384 dottorlucaelli@gmail.com

Locations
Italy
Fondazione IRCCS Ca' Granda Recruiting
Milano, Italy, 20122
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Investigators
Principal Investigator: Luca Elli, MD Fondazione IRCCS Cà Granda
  More Information

Responsible Party: Prof. Pier Mannuccio Mannucci, Scientific Director, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT01867151     History of Changes
Other Study ID Numbers: BMS2013
First Submitted: May 29, 2013
First Posted: June 3, 2013
Last Update Posted: June 3, 2013
Last Verified: May 2013

Keywords provided by Prof. Pier Mannuccio Mannucci, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:
Burning Mouth Syndrome
Gluten
Gluten Free Diet

Additional relevant MeSH terms:
Syndrome
Burns
Burning Mouth Syndrome
Disease
Pathologic Processes
Wounds and Injuries
Mouth Diseases
Stomatognathic Diseases