Aphthous StomatitisPhase 2AphtoseNCT02789605
Effectiveness and Safety of Lactobacillus Rhamnosus Lcr35® in the Treatment of Recurrent Aphthous Stomatitis
A Phase 2 study testing Bacilor in people with Aphthous Stomatitis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Recurrent aphthous stomatitis (RAS) is a frequent condition characterized by recurrent and painful oral ulcers with unknown pathophysiology. Recent studies suggest that a dysregulation of the oral microbiota may be implicated. Currently, therapies for RAS are limited by severe side effects or inconstant effectiveness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aphthous Stomatitis
- What is being tested?
- Bacilor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jan 2018to 15 Jul 2020
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 year-old or more
- Recurrent idiopathic aphtous stomatitis with at least one new lesion per month during the past 6 months.
Who cannot join
- Symptomatic aphtosis associated with Crohn or Behcet disease
- Concomitant use of probiotic for any other reason
- Systemic use of colchicine or steroids or immunosuppressive drugs during the past 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Idiopathic and Recurrent Aphthous Stomatitis by a Probiotic, the Lactobacillus Rhamnosus Lcr35® : a Randomized, Double Blind and Placebo-controlled Trial
Recurrent aphthous stomatitis (RAS) is a frequent condition characterized by recurrent and painful oral ulcers with unknown pathophysiology. Recent studies suggest that a dysregulation of the oral microbiota may be implicated. Currently, therapies for RAS are limited by severe side effects or inconstant effectiveness. The aim of this study is to assess the effectiveness and safety of a probiotic, the Lactobacillus rhamnosus Lcr35® , in the treatment of RAS. A placebo-controlled, parallel study will be conducted in 40 subjects with RAS. Treatment consisted on the administration of the daily probiotics or placebo during 3 months.All patients will be then followed up for additional 3months without treatment. The main outcome measure will be the number of occurring aphtae.
Read the detailed description
Recurrent aphthous stomatitis (RAS) is the most common chronic disease of the oral cavity, affecting 5-25% of the population. This condition is characterized by recurrent and painful oral ulcers. The discomfort of RAS can impact negatively on quality of life that is why the therapeutic demand is strong. Currently, there is no curative treatment for RAS, and suspensive treatments such as colchicine and thalidomide are no definitive or can induce severe side effects. The pathophysiology of RAS remains largely unknown. Recent studies suggest that a dysregulation of the oral microbiota may be implicated. Increasing data underline the potential interest of using probiotics in conditions due to microbiota disorder. To the best of our knowledge, no study has evaluated the effectiveness of probiotic in RAS. The main objective of this double blind clinical trial is to evaluate the effectiveness and safety of a probiotic, the Lactobacillus rhamnosus Lcr35®, in the treatment of RAS in adults. 40 patients suffering from minor RAS for 6 months will be included and randomly assigned to 2 group of 20. Patients of group A will took the Lactobacillus rhamnosus Lcr35® orally daily for 3 months and patients of group B will took the placebo similarly. All patients will be then followed up for 3 additional months without treatment. The primary outcome measure will be the monthly number of aphthae occurring during the 3 months of treatment. The secondary outcomes measures will be the monthly number of aphthae occurring during the 3 months of follow up, the pain reduction, the impact on quality of life according to the OHIP-14 score and the side effects.
- Conditions
- Aphthous Stomatitis
- Being tested
- Bacilor, Placebo
- Keywords
- Aphthous Stomatitis [C07.465.864.750]
- Medical subject headings
- Stomatitis, Aphthous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BacilorDrug
Patient receiving Lactobacillus rhamnosus Lcr35®, orally taken, 4 times a day, during 3 months. Then all patients will be then followed up for 3 additional months without treatment.
PlaceboDrug
Patients of group B will took the placebo similarly at the Lactobacillus rhamnosus Lcr35® orally . All patients will be then followed up for 3 additional months without treatment.
| Study group | Role | What they receive |
|---|---|---|
| Bacilor | Experimental | Patient receiving Lactobacillus rhamnosus Lcr35®, orally taken, 4 times a day, during 3 months Receives: Drug: Bacilor |
| Placebo | Placebo comparator | Patient receiving placebo, orally taken, 4 times a day, during 3 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of aphtae
The number of aphtae
Measured: from baseline at 3 months
Secondary outcomes (2)
Quality of life
the impact on quality of life according to the OHIP-14 score
Measured: At 3 months
Satisfaction patient
the satisfaction of the patients about effectiveness and safety of the treatments by EVA.
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study start4 Jan 2018
- Primary completion25 Nov 2019
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aphthous StomatitisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Passeron Thierry, PhD, Principal investigator, CHU de Nice, Hôpital Archet, Dermatologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02789605
- Sponsor's protocol ID
- 15-PP-13
- Acronym
- Aphtose
- Status last verified
- Dec 2019
- First submitted
- 14 Apr 2016
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dugourd PM, Martin H, Fontas E, Velin M, Montaudie H, Lacour JP, Passeron T. Probiotics for recurrent idiopathic aphthous stomatitis in adults: a placebo-controlled randomized trial. J Eur Acad Dermatol Venereol. 2020 May;34(5):e239-e240. doi: 10.1111/jdv.16199. Epub 2020 Feb 16. No abstract available.
PubMed 31954066
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Idiopathic and Recurrent Aphthous Stomatitis by a Probiotic, the Lactobacillus Rhamnosus Lcr35® : a Randomized, Double Blind and Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02789605
- Acronym / sponsor ID
- Aphtose / 15-PP-13
- Conditions
- Aphthous Stomatitis
- Keywords
- Aphthous Stomatitis [C07.465.864.750]
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 3 Jun 2016 (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.
Recurrent aphthous stomatitis (RAS) is a frequent condition characterized by recurrent and painful oral ulcers with unknown pathophysiology. Recent studies suggest that a dysregulation of the oral microbiota may be implicated. Currently, therapies for RAS are limited by severe side effects or inconstant effectiveness. The aim of this study is to assess the effectiveness and safety of a probiotic, the Lactobacillus rhamnosus Lcr35® , in the treatment of RAS. A placebo-controlled, parallel study will be conducted in 40 subjects with RAS. Treatment consisted on the administration of the daily probiotics or placebo during 3 months.All patients will be then followed up for additional 3months without treatment. The main outcome measure will be the number of occurring aphtae.
Detailed description
Recurrent aphthous stomatitis (RAS) is the most common chronic disease of the oral cavity, affecting 5-25% of the population. This condition is characterized by recurrent and painful oral ulcers. The discomfort of RAS can impact negatively on quality of life that is why the therapeutic demand is strong. Currently, there is no curative treatment for RAS, and suspensive treatments such as colchicine and thalidomide are no definitive or can induce severe side effects. The pathophysiology of RAS remains largely unknown. Recent studies suggest that a dysregulation of the oral microbiota may be implicated. Increasing data underline the potential interest of using probiotics in conditions due to microbiota disorder. To the best of our knowledge, no study has evaluated the effectiveness of probiotic in RAS. The main objective of this double blind clinical trial is to evaluate the effectiveness and safety of a probiotic, the Lactobacillus rhamnosus Lcr35®, in the treatment of RAS in adults. 40 patients suffering from minor RAS for 6 months will be included and randomly assigned to 2 group of 20. Patients of group A will took the Lactobacillus rhamnosus Lcr35® orally daily for 3 months and patients of group B will took the placebo similarly. All patients will be then followed up for 3 additional months without treatment. The primary outcome measure will be the monthly number of aphthae occurring during the 3 months of treatment. The secondary outcomes measures will be the monthly number of aphthae occurring during the 3 months of follow up, the pain reduction, the impact on quality of life according to the OHIP-14 score and the side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bacilor | Experimental | Drug: BacilorPatient receiving Lactobacillus rhamnosus Lcr35®, orally taken, 4 times a day, during 3 months |
| Placebo | Placebo comparator | Drug: PlaceboPatient receiving placebo, orally taken, 4 times a day, during 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 year-old or more
- Recurrent idiopathic aphtous stomatitis with at least one new lesion per month during the past 6 months.
Key exclusion criteria (3 listed)
- Symptomatic aphtosis associated with Crohn or Behcet disease
- Concomitant use of probiotic for any other reason
- Systemic use of colchicine or steroids or immunosuppressive drugs during the past 3 months
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 |
|---|---|---|
| BacilorPatient receiving Lactobacillus rhamnosus Lcr35®, orally taken, 4 times a day, during 3 months. Then all patients will be then followed up for 3 additional months without treatment. | Drug | Bacilor |
| PlaceboPatients of group B will took the placebo similarly at the Lactobacillus rhamnosus Lcr35® orally . All patients will be then followed up for 3 additional months without treatment. | Drug | Placebo |
Primary outcome
number of aphtae
Time frame: from baseline at 3 months
The number of aphtae
2 secondary outcomes
Quality of life
Time frame: At 3 months
Satisfaction patient
Time frame: At 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Results publication: PubMed 31954066Dugourd PM, Martin H, Fontas E, Velin M, Montaudie H, Lacour JP, Passeron T. Probiotics for recurrent idiopathic aphthous stomatitis in adults: a placebo-controlled randomized trial. J Eur Acad Dermatol Venereol. 2020 May;34(5):e239-e240. doi: 10.1111/jdv.16199. Epub 2020 Feb 16. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Aphthous Stomatitis
Not yet recruiting
Recurrent Aphthous Stomatitis Management in Children Using Diode Laser 980 Nanometer Versus Hyaluronic Acid Gel (RCT)
Apthous Ulcer
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
Not yet recruitingPhase 1
A Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers
Oral Ulcer, Oral Mucositis
RecruitingPhase 2/3
Oxygenated Gel Therapy in the Management of Oral Aphthous Ulcers
Aphthus Ulcer
RecruitingPhase 2
Evaluation of Topical Rebamipide Versus Topical Betamethasone for Treatment of Oral Aphthous Ulcers
Oral Aphthous Ulcers
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.
Passeron Thierry, PhD principal investigator
CHU de Nice, Hôpital Archet, Dermatologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bacilor in people with Aphthous Stomatitis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 24 Mar 2026. 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 France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of aphtae (time frame: from baseline at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02789605, which also lists 1 linked publication.
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 24 Mar 2026.