Burning Mouth SyndromeNCT01867151
Effect of Gluten Free Diet in Patients With Burning Mouth Syndrome
A study testing Gluten Free Diet and Normal Diet in people with Burning Mouth Syndrome, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Burning Mouth Syndrome
- What is being tested?
- Gluten Free Diet and Normal Diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- May 2013to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Primary BMS
Who cannot join
- Celiac Disease
- Psychiatric Disorders
- intestinal autoimmune diseases
- Ongoing cancer
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda
Milan, Italy, 20122
About this study
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
- Conditions
- Burning Mouth Syndrome
- Being tested
- Gluten Free Diet, Normal Diet
- Keywords
- Burning Mouth Syndrome, Gluten, Gluten Free Diet
- Medical subject headings
- Burning Mouth Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gluten Free DietDietary supplement
Normal DietDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Gluten free diet | Experimental | BMS patients following a GFD Receives: Dietary Supplement: Gluten Free Diet |
| Normal Diet | Sham comparator | Patients with BMS maintaing a normal diet Receives: Dietary Supplement: Normal Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral pain
oral pain will be evaluated by means of visual analogue scales
Measured: 28 days
Secondary outcomes (1)
Quality of Life
quality of life of patients with BMS will be evaluated by means of SF36 questionnaire
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2013 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burning Mouth SyndromeStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Pier Mannuccio Mannucci, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Investigators
- Luca Elli, MD, Principal investigator, Fondazione IRCCS Cà Granda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867151
- Sponsor's protocol ID
- BMS2013
- Status last verified
- May 2013
- First submitted
- 29 May 2013
- Last updated
- 3 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effetto Della Dieta Priva di Glutine in Soggetti Con BMS
- ClinicalTrials.gov ID
- NCT01867151
- Acronym / sponsor ID
- BMS2013
- Conditions
- Burning Mouth Syndrome
- Keywords
- Burning Mouth Syndrome, Gluten, Gluten Free Diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2013 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 3 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gluten free diet | Experimental | Dietary Supplement: Gluten Free DietBMS patients following a GFD |
| Normal Diet | Sham comparator | Dietary Supplement: Normal DietPatients with BMS maintaing a normal diet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Primary BMS
Key exclusion criteria (4 listed)
- Celiac Disease
- Psychiatric Disorders
- intestinal autoimmune diseases
- Ongoing cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gluten Free Diet | Dietary supplement | Gluten free diet |
| Normal Diet | Dietary supplement | Normal Diet |
Primary outcome
oral pain
Time frame: 28 days
oral pain will be evaluated by means of visual analogue scales
1 secondary outcome
Quality of Life
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Elli, MD principal investigator
Fondazione IRCCS Cà Granda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluten Free Diet and Normal Diet in people with Burning Mouth Syndrome, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luca Elli, MD (00390255033384, dottorlucaelli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oral pain (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2013.