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Probiotic Response in Periodontal Disease (MicroPerio)

2026年7月16日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

100

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター：Placebo
Placebo lozenge (Ingredients: Isomalt, xylitol, peppermint flavor, menthol flavor and calcium sterate)
ダイエットサプリメント：Placebo Lozenge
Daily placebo lozenge.
実験的：Probiotic
Probiotic lozenge (Ingredients: Limosilactobacillus reuteri, isomalt, xylitol, peppermint flavor, menthol flavor and calcium sterate)
ダイエットサプリメント：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Matrix metalloproteinase-8 (MMP-8)in gingival crevicular fluid (GCF)
時間枠：Change from baseline to week 12
MMP-8 is a validated biomarker of periodontal collagen breakdown
Change from baseline to week 12

二次結果の測定

結果測定
メジャーの説明
時間枠
C-reactive protein (CRP) in saliva and plasma
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of New Hampshire

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年10月1日

一次修了 (推定)

2027年11月1日

研究の完了 (推定)

2028年7月1日

試験登録日

最初に提出

2026年7月16日

QC基準を満たした最初の提出物

2026年7月16日

最初の投稿 (実際)

2026年7月21日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月21日

QC基準を満たした最後の更新が送信されました

2026年7月16日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • UNH-17-FY2026_181-01

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

歯周病の臨床試験

Placebo Lozengeの臨床試験

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スポンサーと協力者

医学的状態

薬物療法

CROs by country

CROs in Netherlands

条件

まれな病気

薬物療法

ダイエットサプリメント

スポンサー/協力者

場所

3
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