Effect of Gluten Free Diet in Patients With Burning Mouth Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor:
Information provided by (Responsible Party):
Prof. Pier Mannuccio Mannucci, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier:
NCT01867151
First received: May 29, 2013
Last updated: May 31, 2013
Last verified: May 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:

Primary Outcome Measures:
  • oral pain [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    oral pain will be evaluated by means of visual analogue scales


Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-Primary BMS

Exclusion Criteria:

  • Celiac Disease
  • Psychiatric Disorders
  • intestinal autoimmune diseases
  • Ongoing cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 29, 2013
Last Updated: May 31, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by 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

ClinicalTrials.gov processed this record on September 16, 2014