Effect of Gluten Free Diet in Patients With Burning Mouth Syndrome
Primary Purpose
Burning Mouth Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Gluten Free Diet
Normal Diet
Sponsored by
About this trial
This is an interventional treatment trial for Burning Mouth Syndrome focused on measuring Burning Mouth Syndrome, Gluten, Gluten Free Diet
Eligibility Criteria
Inclusion Criteria:
-Primary BMS
Exclusion Criteria:
- Celiac Disease
- Psychiatric Disorders
- intestinal autoimmune diseases
- Ongoing cancer
Sites / Locations
- Fondazione IRCCS Ca' GrandaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Gluten free diet
Normal Diet
Arm Description
BMS patients following a GFD
Patients with BMS maintaing a normal diet
Outcomes
Primary Outcome Measures
oral pain
oral pain will be evaluated by means of visual analogue scales
Secondary Outcome Measures
Quality of Life
quality of life of patients with BMS will be evaluated by means of SF36 questionnaire
Full Information
NCT ID
NCT01867151
First Posted
May 29, 2013
Last Updated
May 31, 2013
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
1. Study Identification
Unique Protocol Identification Number
NCT01867151
Brief Title
Effect of Gluten Free Diet in Patients With Burning Mouth Syndrome
Official Title
Effetto Della Dieta Priva di Glutine in Soggetti Con BMS
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
March 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burning Mouth Syndrome
Keywords
Burning Mouth Syndrome, Gluten, Gluten Free Diet
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gluten free diet
Arm Type
Experimental
Arm Description
BMS patients following a GFD
Arm Title
Normal Diet
Arm Type
Sham Comparator
Arm Description
Patients with BMS maintaing a normal diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Gluten Free Diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Normal Diet
Primary Outcome Measure Information:
Title
oral pain
Description
oral pain will be evaluated by means of visual analogue scales
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Quality of Life
Description
quality of life of patients with BMS will be evaluated by means of SF36 questionnaire
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-Primary BMS
Exclusion Criteria:
Celiac Disease
Psychiatric Disorders
intestinal autoimmune diseases
Ongoing cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luca Elli, MD
Phone
00390255033384
Email
dottorlucaelli@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luca Elli, MD
Organizational Affiliation
Fondazione IRCCS Cà Granda
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione IRCCS Ca' Granda
City
Milano
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Effect of Gluten Free Diet in Patients With Burning Mouth Syndrome
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