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RECRUITING
NCT07907224

Characterization of Small Intestinal Bacterial Overgrowth and Intestinal Barrier-Related Biomarkers in Patients With Severe Periodontitis: A Pilot Prospective Longitudinal Observational Cohort Study

Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy

View on ClinicalTrials.gov

Summary

Periodontitis is a chronic inflammatory disease characterized by dysbiotic subgingival biofilms, inflammation, and progressive destruction of the tooth-supporting tissues. Beyond the local periodontal lesion, periodontal inflammation may contribute to systemic inflammatory burden through the dissemination of microbial products and inflammatory mediators. The oral cavity and intestinal tract are closely connected through continuous microbial exposure, swallowing of oral microorganisms, host immune pathways, and systemic circulation. Emerging evidence suggests that periodontal inflammation may be associated with alterations of the intestinal microbial environment and gut barrier function. However, the human evidence remains heterogeneous and does not currently establish a causal relationship between periodontitis and intestinal dysbiosis or small intestinal bacterial overgrowth (SIBO). SIBO represents an abnormal increase and/or alteration of bacterial populations in the small intestine and may be associated with gastrointestinal symptoms and intestinal microbial imbalance. The occurrence of SIBO in patients with advanced periodontitis has not been adequately characterized. Consequently, determining how frequently SIBO is detected in a clinically well-characterized cohort of participants with Stage III periodontitis may provide useful exploratory data and may support future controlled studies. Alterations in the intestinal microbial environment may be accompanied by changes in intestinal barrier function and increased systemic exposure to bacterial products. Zonulin has been investigated as a biomarker related to intestinal barrier regulation, while lipopolysaccharide-binding protein (LBP), or another prespecified bacterial-exposure marker depending on the finalized laboratory assay, may provide information regarding systemic exposure to bacterial products. These biomarkers should be interpreted as indirect biological indicators rather than as direct measurements of intestinal permeability. The present study therefore approaches the oral-gut-systemic interface from an exploratory clinical perspective. It does not aim to demonstrate that periodontitis causes SIBO. Instead, it seeks to characterize the occurrence of SIBO in participants with severe periodontitis and to explore whether SIBO is accompanied by alterations in intestinal barrier-related biomarkers and systemic exposure to bacterial products. The longitudinal component will further examine whether improvement in periodontal clinical status following routine, clinically indicated periodontal therapy is accompanied by changes in SIBO status and these biological markers.

Official title: The Intestinal Microbiome: From Systemic Impact to Periodontal Supporting Tissues

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

20

Start Date

2026-10-02

Completion Date

2029-09-30

Last Updated

2026-10-30

Healthy Volunteers

No

Locations (1)

Ambulatoriul de Stomatologie al SCJU Cluj-Napoca, România

Cluj-Napoca, Romania