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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01867151
Other study ID # BMS2013
Secondary ID
Status Recruiting
Phase N/A
First received May 29, 2013
Last updated May 31, 2013
Start date May 2013
Est. completion date March 2014

Study information

Verified date May 2013
Source Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Contact Luca Elli, MD
Phone 00390255033384
Email dottorlucaelli@gmail.com
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date March 2014
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

-Primary BMS

Exclusion Criteria:

- Celiac Disease

- Psychiatric Disorders

- intestinal autoimmune diseases

- Ongoing cancer

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Gluten Free Diet

Normal Diet


Locations

Country Name City State
Italy Fondazione IRCCS Ca' Granda Milano

Sponsors (1)

Lead Sponsor Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary oral pain oral pain will be evaluated by means of visual analogue scales 28 days No
Secondary Quality of Life quality of life of patients with BMS will be evaluated by means of SF36 questionnaire 28 days No
See also
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Completed NCT02686359 - Opiorphin Levels in Fluids of Burning Mouth Syndrome Patients (OPIODYN) N/A
Completed NCT05309681 - Salivary Melatonin Levels and Sleep Quality in Patients With Burning Mouth Syndrome