Effect of Gluten Free Diet in Patients With Burning Mouth Syndrome

Not Applicable

• Conditions: Burning Mouth Syndrome
• Interventions: Dietary Supplement: Gluten Free Diet; Dietary Supplement: Normal Diet

• Registration Number: NCT01867151
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-05
• Study Start: 2013-05
• Primary Completion: 2013-05
• Study First Submitted: 2013-05-29
• Study First Submitted QC: 2013-05-31
• Last Update Submitted: 2013-05-31
• Study First Posted: 2013-06-03
• Last Update Posted: 2013-06-03
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

-Primary BMS

Exclusion Criteria

• Celiac Disease
• Psychiatric Disorders
• intestinal autoimmune diseases
• Ongoing cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gluten free diet	Gluten Free Diet	BMS patients following a GFD
Normal Diet	Normal Diet	Patients with BMS maintaing a normal diet

Primary Outcome Measures

Name	Time	Method
oral pain	28 days	oral pain will be evaluated by means of visual analogue scales

Secondary Outcome Measures

Name	Time	Method
Quality of Life	28 days	quality of life of patients with BMS will be evaluated by means of SF36 questionnaire

Trial Locations

Locations (1)

Fondazione IRCCS Ca' Granda; 🇮🇹 Milano, Italy