Effect of Gluten Free Diet in Patients With Burning Mouth Syndrome

This study is currently recruiting participants.
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
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:
Burning Mouth Syndrome
Burns
Mouth Diseases
Stomatognathic Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on April 17, 2014