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Effect of Gluten Free Diet in Patients With Burning Mouth Syndrome

I

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Unknown

Conditions

Burning Mouth Syndrome

Treatments

Dietary Supplement: Gluten Free Diet
Dietary Supplement: Normal Diet

Study type

Interventional

Funder types

Other

Identifiers

NCT01867151
BMS2013

Details and patient eligibility

About

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

Enrollment

40 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

-Primary BMS

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Gluten free diet
Experimental group
Description:
BMS patients following a GFD
Treatment:
Dietary Supplement: Gluten Free Diet
Normal Diet
Sham Comparator group
Description:
Patients with BMS maintaing a normal diet
Treatment:
Dietary Supplement: Normal Diet

Trial contacts and locations

1

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Central trial contact

Luca Elli, MD

Data sourced from clinicaltrials.gov

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