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Probiotic Response in Periodontal Disease (MicroPerio)

16. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

100

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: Placebo
Placebo lozenge (Ingredients: Isomalt, xylitol, peppermint flavor, menthol flavor and calcium sterate)
Nahrungsergänzungsmittel: Placebo Lozenge
Daily placebo lozenge.
Experimental: Probiotic
Probiotic lozenge (Ingredients: Limosilactobacillus reuteri, isomalt, xylitol, peppermint flavor, menthol flavor and calcium sterate)
Nahrungsergänzungsmittel: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Matrix metalloproteinase-8 (MMP-8)in gingival crevicular fluid (GCF)
Zeitfenster: Change from baseline to week 12
MMP-8 is a validated biomarker of periodontal collagen breakdown
Change from baseline to week 12

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
C-reactive protein (CRP) in saliva and plasma
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of New Hampshire

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Oktober 2026

Primärer Abschluss (Geschätzt)

1. November 2027

Studienabschluss (Geschätzt)

1. Juli 2028

Studienanmeldedaten

Zuerst eingereicht

16. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

16. Juli 2026

Zuerst gepostet (Tatsächlich)

21. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

21. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

16. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • UNH-17-FY2026_181-01

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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Bedingungen

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