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Probiotic Response in Periodontal Disease (MicroPerio)

16 juli 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

100

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  1. 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.
  2. 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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. Pregnancy or breastfeeding: Physiological changes during pregnancy and lactation may influence periodontal status, immune function, and microbiome composition.
  6. Having fewer than 20 natural teeth: Adequate natural dentition is required to support standardized periodontal assessments and reliable biospecimen collection.
  7. Use of removable dentures: Denture use alters the oral microbiome and local inflammatory environment and may compromise the validity of periodontal outcome measures.
  8. 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.
  9. Ongoing participation in another clinical trial: Concurrent participation in another trial may introduce overlapping interventions or behavioral changes that could compromise internal validity.
  10. Lack of mobility or physical independence: Physical limitations may make participation burdensome or interfere with attendance at study visits and completion of study procedures.
  11. 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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: Placebo
Placebo lozenge (Ingredients: Isomalt, xylitol, peppermint flavor, menthol flavor and calcium sterate)
Kosttillskott: Placebo Lozenge
Daily placebo lozenge.
Experimentell: Probiotic
Probiotic lozenge (Ingredients: Limosilactobacillus reuteri, isomalt, xylitol, peppermint flavor, menthol flavor and calcium sterate)
Kosttillskott: Probiotic Blend Lozenge
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Matrix metalloproteinase-8 (MMP-8)in gingival crevicular fluid (GCF)
Tidsram: Change from baseline to week 12
MMP-8 is a validated biomarker of periodontal collagen breakdown
Change from baseline to week 12

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
C-reactive protein (CRP) in saliva and plasma
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of New Hampshire

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 oktober 2026

Primärt slutförande (Beräknad)

1 november 2027

Avslutad studie (Beräknad)

1 juli 2028

Studieregistreringsdatum

Först inskickad

16 juli 2026

Först inskickad som uppfyllde QC-kriterierna

16 juli 2026

Första postat (Faktisk)

21 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

21 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • UNH-17-FY2026_181-01

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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