Burning Mouth Syndrome Clinical Trial
Official title:
Effetto Della Dieta Priva di Glutine in Soggetti Con BMS
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
| 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Italy | Fondazione IRCCS Ca' Granda | Milano |
| Lead Sponsor | Collaborator |
|---|---|
| Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
Italy,
| 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 |
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