Pemphigoid, Benign Mucous MembraneMICROPCNCT06291350
Peridontal and Intestinal Microbiota in Patients With Gingival Scarring Pemphigoid
An observational study of Pemphigoid, Benign Mucous Membrane and Gingivitis Hyperplastic, run by Centre Hospitalier Universitaire de Nice at 3 sites in France.
Trial summary
Patients suffering from Mucous Membrane Pemphigoid with desquamative gingivitis (MMPg) generally present a more degraded periodontal condition compared with controls. Bullous disease could represent a risk factor for plaque-induced periodontal disease, and vice versa. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pemphigoid, Benign Mucous Membrane, Gingivitis Hyperplastic
- What is being tested?
- Plaque sampling and stool collection and periodontal examination
- How many people
- 45 participants
- Where
- 3 sitesFrance
- Study dates
- 24 Oct 2024to 15 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cases: 15 adult patients (over 18 years of age) with CP with erosive gingival expression (CP patients). Control group 1: 15 adult patients (over 18 years of age) without CP, matched to cases on age, gender and periodontal conditions. Control group 2: 15 adult patients (over 18 years of age) without CP, with healed periodontal conditions, matched to cases on age and gender.
Who may be able to join
- Adults (over 18), non-smokers Arm 1
- MMPg (initial, persistent despite medical treatment, recurrent), periodontitis Arm 2
- non-MMPg, periodontitis, matched to cases on age, gender and severity of periodontitis
- Arm 3:
- non-MMPg, healthy periodontal conditions, matched to cases on age and gender
Who cannot join
- Antibiotic therapy and mechanical periodontal treatment within 3 months prior to study, other chronic general illness of immune or digestive origin
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Nice University Hospital
Nice, 06000
Sophie DRIDI, PUPH, 04 92 03 30 07, dr.sm.dridi@free.fr
Rachida Yatimi, 04 92 03 30 07, yatimi.r@chu-nice.fr
- Recruiting
Paris hospital Pitié Salpetrière (APHP)
Paris, 75013
Juliette ROCHEFORT, 0142178416, juliette.rochefort@aphp.fr
Juliette ROCHEFORT
- Recruiting
Paris hospital Bretonneau (APHP)
Paris, 75018
Anne-Laure EJEIL, 0153111800, anne-laure.ejeil@aphp.fr
Anne-Laure AJEIL
About this study
Official title: Characterization of Peroodontal and Intestinal Microbiota in Patients With Gingival Scarring Pemphigoid: a Matched Controlled Study
Patients suffering from Mucous Membrane Pemphigoid with desquamative gingivitis (MMPg) generally present a more degraded periodontal condition compared with controls. Bullous disease could represent a risk factor for plaque-induced periodontal disease, and vice versa.
Indeed, the dysbiotic periodontal microbiota could aggravate the gingival damage specific to MMP, either directly by activating inflammatory pathways, or indirectly by degrading cellular and matrix components. On the other hand, areas of erosive gingiva generated by the autoimmune process could increase the virulent power of periodontal pathobionts, by representing accessible, nutrient-rich connective surfaces. Moreover, in recent years, bacterial studies based on a high-throughput metagenomic approach have suggested the existence of a relationship between the oral and intestinal microbiota in patients with degraded periodontal conditions and suffering from autoimmune inflammatory diseases (inflammatory bowel disease, acute graft-versus-host disease). This relationship can also be envisaged in MMPg patients who meet the conditions that allow this type of pathological process to occur: autoimmune disease; disruption of the gingival epithelial barrier in erosive gingival areas (increasing the risk of antigen exposure); large amounts of thick plaque; degraded periodontal condition with the presence of numerous periodontal pockets from which periodontopathogenic bacteria can translocate intra-tissularly and cause distant adverse consequences.
The main aim of this observational, multicentre, case-control, matched study is to compare the composition of the periodontal microbiota between MMPg patients and control patients (arm 2 and arm 3). The secondary objectives are to compare the composition of periodontal and intestinal microbiota in cases and control patients (arm 2 and arm 3), to compare periodontal microbiota composition in cases and control patients (arm 2) according to periodontitis severity, and to compare gut microbiota composition between cases and control patients (arm 2 and arm3). To date, no such study exists.
- Being tested
- Plaque sampling and stool collection, periodontal examination
- Medical subject headings
- Pemphigoid, Benign Mucous Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plaque sampling and stool collectionOther
Characterization of the periodontal and digestive microbiota (metagenomic analysis), assessment of clinical attachment loss and alveolysis
periodontal examinationOther
Characterization of the periodontal and digestive microbiota (metagenomic analysis), assessment of clinical attachment loss and alveolysis
| Study group | Role | What they receive |
|---|---|---|
| MMPg and periodontitis | 15 adult patients with MMPg and periodontitis Receives: Other: Plaque sampling and stool collection; Other: periodontal examination | |
| no MMPg and periodontitis | 15 adult patients not suffering from MMPg with periodontitis Receives: Other: Plaque sampling and stool collection; Other: periodontal examination | |
| no MMPg with healthy periodontal conditions | 15 adult patients not suffering from MMPg with healthy periodontal conditions Receives: Other: Plaque sampling and stool collection; Other: periodontal examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
composition of the periodontal microbiota
Compare the composition (name and number of bacterial colonies) of the periodontal microbiota between patients with MMPg and periodontitis (cases) and control patients (non-MMPg with case-matched periodontitis or non-MMPg with healthy periodontium)
Identification and quantification of bacterial populations in the subgingival plaque of cases and controls: global shotgun metagenomic approach, genetic sequencing on a third-generation sequencer
Measured: at inclusion
Secondary outcomes (4)
Compare the composition (name and number of bacterial colonies) of periodontal in MMP and control patients (arm 2 and arm 3).
Measured: at inclusion
Compare the composition (name and number of bacterial colonies) intestinal microbiota in MMP and control patients (arm 2 and arm 3).
stool sampling at the patient's home after inclusion
Measured: at inclusion
Compare (name and number of bacterial colonies) periodontal microbiota composition in MMP and control patients (arm 2) according to periodontitis severity (non-severe/severe)
Measured: at inclusion
Compare (name and number of bacterial colonies) gut microbiota composition between MMP and control patients (arm 2 and arm3)
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start24 Oct 2024
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pemphigoid, Benign Mucous MembraneStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291350
- Sponsor's protocol ID
- 23-AOI-05
- Acronym
- MICROPC
- Status last verified
- Mar 2025
- First submitted
- 26 Feb 2024
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Peroodontal and Intestinal Microbiota in Patients With Gingival Scarring Pemphigoid: a Matched Controlled Study
- ClinicalTrials.gov ID
- NCT06291350
- Acronym / sponsor ID
- MICROPC / 23-AOI-05
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 4 Mar 2024 (actual)
- 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.
Patients suffering from Mucous Membrane Pemphigoid with desquamative gingivitis (MMPg) generally present a more degraded periodontal condition compared with controls. Bullous disease could represent a risk factor for plaque-induced periodontal disease, and vice versa.
Indeed, the dysbiotic periodontal microbiota could aggravate the gingival damage specific to MMP, either directly by activating inflammatory pathways, or indirectly by degrading cellular and matrix components. On the other hand, areas of erosive gingiva generated by the autoimmune process could increase the virulent power of periodontal pathobionts, by representing accessible, nutrient-rich connective surfaces. Moreover, in recent years, bacterial studies based on a high-throughput metagenomic approach have suggested the existence of a relationship between the oral and intestinal microbiota in patients with degraded periodontal conditions and suffering from autoimmune inflammatory diseases (inflammatory bowel disease, acute graft-versus-host disease). This relationship can also be envisaged in MMPg patients who meet the conditions that allow this type of pathological process to occur: autoimmune disease; disruption of the gingival epithelial barrier in erosive gingival areas (increasing the risk of antigen exposure); large amounts of thick plaque; degraded periodontal condition with the presence of numerous periodontal pockets from which periodontopathogenic bacteria can translocate intra-tissularly and cause distant adverse consequences.
The main aim of this observational, multicentre, case-control, matched study is to compare the composition of the periodontal microbiota between MMPg patients and control patients (arm 2 and arm 3). The secondary objectives are to compare the composition of periodontal and intestinal microbiota in cases and control patients (arm 2 and arm 3), to compare periodontal microbiota composition in cases and control patients (arm 2) according to periodontitis severity, and to compare gut microbiota composition between cases and control patients (arm 2 and arm3). To date, no such study exists.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MMPg and periodontitis | – | Other: Plaque sampling and stool collection, Other: periodontal examination15 adult patients with MMPg and periodontitis |
| no MMPg and periodontitis | – | Other: Plaque sampling and stool collection, Other: periodontal examination15 adult patients not suffering from MMPg with periodontitis |
| no MMPg with healthy periodontal conditions | – | Other: Plaque sampling and stool collection, Other: periodontal examination15 adult patients not suffering from MMPg with healthy periodontal conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cases: 15 adult patients (over 18 years of age) with CP with erosive gingival expression (CP patients). Control group 1: 15 adult patients (over 18 years of age) without CP, matched to cases on age, gender and periodontal conditions. Control group 2: 15 adult patients (over 18 years of age) without CP, with healed periodontal conditions, matched to cases on age and gender.
Key inclusion criteria (5 listed)
- Adults (over 18), non-smokers Arm 1
- MMPg (initial, persistent despite medical treatment, recurrent), periodontitis Arm 2
- non-MMPg, periodontitis, matched to cases on age, gender and severity of periodontitis
- non-MMPg, healthy periodontal conditions, matched to cases on age and gender
Key exclusion criteria (1 listed)
- Antibiotic therapy and mechanical periodontal treatment within 3 months prior to study, other chronic general illness of immune or digestive origin
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 |
|---|---|---|
| Plaque sampling and stool collectionCharacterization of the periodontal and digestive microbiota (metagenomic analysis), assessment of clinical attachment loss and alveolysis | Other | MMPg and periodontitis, no MMPg and periodontitis, no MMPg with healthy periodontal conditions |
| periodontal examinationCharacterization of the periodontal and digestive microbiota (metagenomic analysis), assessment of clinical attachment loss and alveolysis | Other | MMPg and periodontitis, no MMPg and periodontitis, no MMPg with healthy periodontal conditions |
Primary outcome
composition of the periodontal microbiota
Time frame: at inclusion
Compare the composition (name and number of bacterial colonies) of the periodontal microbiota between patients with MMPg and periodontitis (cases) and control patients (non-MMPg with case-matched periodontitis or non-MMPg with healthy periodontium) Identification and quantification of bacterial populations in the subgingival plaque of cases and controls: global shotgun metagenomic approach, genetic sequencing on a third-generation sequencer
4 secondary outcomes
Compare the composition (name and number of bacterial colonies) of periodontal in MMP and control patients (arm 2 and arm 3).
Time frame: at inclusion
Compare the composition (name and number of bacterial colonies) intestinal microbiota in MMP and control patients (arm 2 and arm 3).
Time frame: at inclusion
Compare (name and number of bacterial colonies) periodontal microbiota composition in MMP and control patients (arm 2) according to periodontitis severity (non-severe/severe)
Time frame: at inclusion
Compare (name and number of bacterial colonies) gut microbiota composition between MMP and control patients (arm 2 and arm3)
Time frame: at inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pemphigoid, Benign Mucous Membrane and Gingivitis Hyperplastic, run by Centre Hospitalier Universitaire de Nice at 3 sites 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 5 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie DRIDI, PUPH (04 92 03 30 07, dr.sm.dridi@free.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composition of the periodontal microbiota (time frame: at inclusion). 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 20 Mar 2025.