Effect of Gluten Free Diet in Patients With Burning Mouth... | NCT01867151

Studies
Effect of Gluten Free Diet in Patients With Burning Mouth Syndrome

NCT01867151

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Status

Unknown status

Last Update Posted

Jun 3, 2013Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Burning Mouth Syndrome

Interventions

Gluten Free Diet
Normal Diet

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

May 2013Estimated

Completion Date

Mar 2014Estimated

First Submitted Date

May 29, 2013

First Submission Date that Met QC Criteria

May 31, 2013

First Posted Date

Jun 3, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 31, 2013

Last Update Posted Date

Jun 3, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Pier Mannuccio Mannucci, Scientific Director, Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoPrincipal Investigator

Lead Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Gluten Free Diet	Dietary Supplement		Gluten free diet
Normal Diet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
oral pain	oral pain will be evaluated by means of visual analogue scales	28 days

Secondary Outcomes

Measure	Description	Time Frame
Quality of Life	quality of life of patients with BMS will be evaluated by means of SF36 questionnaire	28 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

-Primary BMS

Exclusion Criteria:

Celiac Disease
Psychiatric Disorders
intestinal autoimmune diseases
Ongoing cancer

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Luca Elli, MD	Contact	00390255033384		dottorlucaelli@gmail.com

Overall Officials

Name	Affiliation	Role
Luca Elli, MD	Fondazione IRCCS Cà Granda	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione IRCCS Ca' Granda	Recruiting	Milan	Italy	20122	Italy

Condition Browse Module

MeSH Terms

ID	Term
D002054	Burning Mouth Syndrome

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D055050	Diet, Gluten-Free

Ancestor Terms

ID	Term
D004035	Diet Therapy
D044623	Nutrition Therapy
D013812	Therapeutics
D004032	Diet
D009747

Browse Leaves

Not provided

Browse Branches

Not provided