NCT01867151

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 3, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

June 3, 2013

Status Verified

May 1, 2013

Enrollment Period

Same day

First QC Date

May 29, 2013

Last Update Submit

May 31, 2013

Conditions

Burning Mouth Syndrome

Keywords

Burning Mouth SyndromeGlutenGluten Free Diet

Outcome Measures

Primary Outcomes (1)

  • oral pain

    oral pain will be evaluated by means of visual analogue scales

    28 days

Secondary Outcomes (1)

  • Quality of Life

    28 days

Study Arms (2)

Gluten free diet

EXPERIMENTAL

BMS patients following a GFD

Dietary Supplement: Gluten Free Diet

Normal Diet

SHAM COMPARATOR

Patients with BMS maintaing a normal diet

Dietary Supplement: Normal Diet

Interventions

Gluten Free DietDIETARY_SUPPLEMENT
Gluten free diet
Normal DietDIETARY_SUPPLEMENT
Normal Diet

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary BMS

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Ca' Granda

Milan, Italy, 20122, Italy

RECRUITING

MeSH Terms

Conditions

Burning Mouth Syndrome

Interventions

Diet, Gluten-Free

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Luca Elli, MD

    Fondazione IRCCS Cà Granda

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luca Elli, MD

CONTACT

00390255033384dottorlucaelli@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientific Director

Study Record Dates

First Submitted

May 29, 2013

First Posted

June 3, 2013

Study Start

May 1, 2013

Primary Completion

May 1, 2013

Study Completion

March 1, 2014

Last Updated

June 3, 2013

Record last verified: 2013-05

Locations

IT(1)