Probiotic Response in Periodontal Disease (MicroPerio)
16 luglio 2026 aggiornato da: Maria Carlota Dao, University of New Hampshire
MicroPerio: Microbiome and Dietary Predictors of Probiotic Response in Periodontal Disease
Probiotics are live microorganisms that can be taken as supplements and have shown promise in playing a beneficial role in improving clinical conditions that are characterized by chronic inflammation, such as periodontal disease (PD).
The human gut microbiome is composed of trillions of bacteria that reside throughout the gastrointestinal tract and has an important role in the modulation of inflammatory responses in the human host.
There is evidence that PD is associated with alterations in the oral and gut microbiomes, suggesting that probiotics may reduce inflammation through microbiome modulation.
However, individual responses to probiotics can be highly variable, and robust predictors of probiotic responsiveness remain poorly defined.
There is also limited knowledge about how the oral and gut microbiome interact even though there is growing evidence for a bidirectional oral-gut axis with implications for host immunity, inflammation, and probiotic responsiveness.
The overarching goal of this project is to identify oral and gut microbiome features that predict responsiveness to probiotic interventions as an adjuvant treatment for PD.
We will conduct a double-blind randomized controlled trial in which New Hampshire adults with stage III PD will be randomized to receive a 12-week adjuvant intervention of either a daily probiotic (n=45) or placebo (n=45) lozenge.
The probiotic intervention will consist of a once daily lozenge containing a standard dose of 200 million CFU of two strains of Limosilactobacillus reuteri (DSM 17938 and ATCC PTA 5289), a commercial formulation demonstrated to be safe and well-tolerated in this population over this treatment length.
The primary outcome to quantify responsiveness to the probiotic as an adjuvant therapeutic for PD will be within-subject change from baseline in inflammatory markers, and oral and gut microbiome composition.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
100
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Maria C Dao, PhD
- Numero di telefono: (603) 862-4723
- Email: carlota.dao@unh.edu
Backup dei contatti dello studio
- Nome: Francesca Schembri, MS
- Email: Francesca.Schembri@unh.edu
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
- Age between 45 and 65 years: Restricting eligibility to this age range reduces potential confounding from age-related comorbidities and ensures adequate natural dentition for standardized gingival crevicular fluid (GCF) sampling.
- Diagnosis of Stage III periodontal disease (PD): Participants must have clinically confirmed Stage III (severe) PD according to the 2017 American Academy of Periodontology/European Federation of Periodontology (AAP/EFP) classification system to ensure consistent disease severity among enrolled participants.
Exclusion Criteria:
- Use of prebiotic, probiotic, or fiber supplements within the previous 6 months: Recent use of microbiome-modulating supplements could alter baseline oral or gut microbial composition and confound assessment of responsiveness to the probiotic intervention.
- Use of antibiotics within the previous 6 months: Antibiotic exposure can cause sustained disruptions to host microbiomes and immune responses, which may confound evaluation of probiotic-related changes in inflammatory and microbial outcomes.
- Systemic diseases affecting the periodontium (uncontrolled diabetes mellitus defined as HbA1c ≥8%, autoimmune diseases): These conditions may independently influence periodontal inflammation, immune responses, and microbiome composition, potentially confounding interpretation of study outcomes.
- History of communicable or chronic diseases that may render study participation unsafe: Certain medical conditions may increase the risk of adverse events associated with study procedures or probiotic exposure.
- Pregnancy or breastfeeding: Physiological changes during pregnancy and lactation may influence periodontal status, immune function, and microbiome composition.
- Having fewer than 20 natural teeth: Adequate natural dentition is required to support standardized periodontal assessments and reliable biospecimen collection.
- Use of removable dentures: Denture use alters the oral microbiome and local inflammatory environment and may compromise the validity of periodontal outcome measures.
- Surgical periodontal disease treatment within the previous 6 months: Recent surgical intervention may induce substantial changes in the periodontal environment, complicating baseline measurement and interpretation of treatment response.
- Ongoing participation in another clinical trial: Concurrent participation in another trial may introduce overlapping interventions or behavioral changes that could compromise internal validity.
- Lack of mobility or physical independence: Physical limitations may make participation burdensome or interfere with attendance at study visits and completion of study procedures.
- Inability to communicate orally or in written English: Because study procedures and consent materials will be conducted in English, adequate language proficiency is required to ensure participants understand study instructions and provide informed consent.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore placebo: Placebo
Placebo lozenge (Ingredients: Isomalt, xylitol, peppermint flavor, menthol flavor and calcium sterate)
|
Daily placebo lozenge.
|
|
Sperimentale: Probiotic
Probiotic lozenge (Ingredients: Limosilactobacillus reuteri, isomalt, xylitol, peppermint flavor, menthol flavor and calcium sterate)
|
L. reuteri is a probiotic that has been shown to inhibit the activity of "red complex" species and reduce PD severity in vitro and in animal models, and has been shown to ameliorate clinical outcomes of PD in human trials.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Matrix metalloproteinase-8 (MMP-8)in gingival crevicular fluid (GCF)
Lasso di tempo: Change from baseline to week 12
|
MMP-8 is a validated biomarker of periodontal collagen breakdown
|
Change from baseline to week 12
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
C-reactive protein (CRP) in saliva and plasma
Lasso di tempo: Change from baseline to week 12
|
CRP is an acute phase protein used as marker of oral and systemic inflammation
|
Change from baseline to week 12
|
|
Interleukin 1β (IL-1β) in saliva and plasma
Lasso di tempo: Change from baseline to week 12
|
Interleukin IL-1β is a pro-inflammatory cytokine measured in saliva and plasma as an indicator of systemic and oral inflammatory response.
|
Change from baseline to week 12
|
|
IL-6 in saliva and plasma
Lasso di tempo: Change from baseline to week 12
|
Il-6 is a pro-inflammatory cytokine measured in saliva and plasma as an indicator of systemic and oral inflammatory response.
|
Change from baseline to week 12
|
|
IL-8 in saliva and plasma
Lasso di tempo: Change from baseline to week 12
|
IL-8 is a chemokine involved in neutrophil recruitment and local inflammatory activity, measured as a marker of periodontal inflammatory response.
|
Change from baseline to week 12
|
|
Tumor necrosis factor-alpha (TNF-α) in saliva and plasma
Lasso di tempo: Change from baseline to week 12
|
TNF-α is a pro-inflammatory cytokine associated with tissue inflammation and periodontal disease activity, measured to assess inflammatory modulation following probiotic supplementation.
|
Change from baseline to week 12
|
|
Oral microbiome composition
Lasso di tempo: Change from baseline to week 12
|
Relative abundance and diversity of bacterial taxa in oral samples, assessed to determine whether probiotic supplementation alters the microbial community associated with periodontal disease.
|
Change from baseline to week 12
|
|
Gut microbiome composition
Lasso di tempo: Change from baseline to week 12
|
Relative abundance and diversity of bacterial taxa in stool samples, assessed to evaluate whether probiotic supplementation affects gut microbial ecology.
|
Change from baseline to week 12
|
|
Oral and gut microbiome functional potential
Lasso di tempo: Change from baseline to week 12
|
Predicted or measured microbial gene pathway profiles, assessed to identify functional microbial features associated with inflammatory response and probiotic responsiveness.
|
Change from baseline to week 12
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 ottobre 2026
Completamento primario (Stimato)
1 novembre 2027
Completamento dello studio (Stimato)
1 luglio 2028
Date di iscrizione allo studio
Primo inviato
16 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
16 luglio 2026
Primo Inserito (Effettivo)
21 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
21 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
16 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- UNH-17-FY2026_181-01
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
All results will be reported in aggregate form using summary statistics. No direct identifiers will be included in publications, presentations, or shared datasets. Analytic files will contain only coded data linked to unique study IDs.
Because the study will enroll participants within a defined age range and geographic region, demographic variables will be reported in grouped categories, and small cell sizes will be aggregated or not report to prevent potential re-identification.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .