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Active, Not Recruiting

NCT Number: NCT06980818

Oral Microbiota Dysbiosis in IBD

This study aims to provide new insights into oral microbiota dysbiosis and IBD. Given the strong association between oral health, microbiome composition, and IBD, all participants will undergo an oral evaluation program conducted by dentists from the Faculty of Dentistry at Universidade Católica Portuguesa (UCP). This program will facilitate the characterization of oral health and its correlation with IBD status.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ULS Viseu Dão-Lafões

Viseu, Viseu District, 3504-509, Portugal

About this study

Inflammatory Bowel Disease (IBD) can impact the entire gastrointestinal tract, from the oral cavity to the anal region, particularly in Crohn's disease, making oral conditions recognized as extraintestinal manifestations. A clear link exists between the severity of IBD and disruptions in the oral microbial community. These extraintestinal manifestations often appear as various lesions in the oral cavity, including aphthous ulcers, recurrent aphthous stomatitis (RAS), granulomas, gingival inflammation, periodontitis, and angular cheilitis. The severity and prevalence of these conditions correlate with the extent of intestinal inflammation.

Research has shown that the intake of excessive amount of imbalanced oral bacteria-such as those resulting from periodontitis-can compromise the gut barrier, leading to impaired gut function, alterations in intestinal microbiota, and immune dysfunction. IBD patients are more susceptible to severe forms of periodontitis compared to individuals with periodontal disease without chronic inflammation. They exhibit greater probing depths, increased plaque levels, bleeding on probing, calculus buildup, and more significant clinical attachment loss (CAL). This bidirectional relationship suggests that while IBD patients are more prone to periodontitis, periodontitis itself may also elevate the risk of developing IBD. The oral cavity hosts over 250 bacterial species, including known periodontal pathogens such as Tannerella forsythia, Streptococcus mutans, Aggregatibacter actinomycetemcomitans, and Porphyromonas gingivalis. When these bacteria exceed normal levels, they can enter the bloodstream through mechanical actions like brushing or dental procedures. Once in circulation, they invade and colonize immune cells such as macrophages and dendritic cells, ultimately reaching and spreading throughout the highly vascularized intestinal tract.

Saliva plays a crucial role in this process, acting as a transporter that facilitates bacterial survival by protecting them from stomach acid through its composition of proteins, lipids, water, and mucins.

While the gut microbiome's role in IBD has been widely studied, limited research has explored the contribution of the oral microbiome to the development of this disease and the associated oral conditions in IBD patients.

Primary Objective:

  • Assess the dysbiosis of the oral microbiome in patients with IBD compared to healthy controls.

Secondary Objectives:

  • Identify key bacterial species in the salivary microbiome that differentiate IBD patients from healthy individuals.
  • Evaluate correlations between oral microbiota composition and clinical parameters (e.g., duration of disease, tobacco use, disease activity, presence of oral symptoms). This will be a cross-sectional observational study designed to assess the dysbiosis of the oral microbiome in patients with IBD compared to healthy controls. The study will involve only one point of evaluation, focusing on saliva samples for microbiome analysis.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age over 18 years old and diagnosis of IBD according to established criteria

Exclusion criteria

  • Recent history of antibiotic treatment (within the preceding month), proton pump inhibitors or non-steroidal anti-inflammatory drugs were exclusion criteria for both patients and controls.

Treatment and study plan

No intervention

Other

No intervention will take place.

Primary outcomes

  1. Oral microbiome characterization

    Time frame: 3 years

    Assess the dysbiosis of the oral microbiome in patients with IBD compared to healthy controls.

Secondary outcomes

  1. Bacterial species characterization in IBD

    Time frame: 3 years

    Identify key bacterial species in the salivary microbiome that differentiate IBD patients from healthy individuals.

  2. Does oral microbiota correlates with disease activity?

    Time frame: 3 years

    Evaluate correlations between oral microbiota composition and clinical parameters (e.g., duration of disease, tobacco use, disease activity, presence of oral symptoms).

Sponsors and collaborators

Lead sponsor

ULS Viseu Dão Lafões

Other

Registry information

Official study title

Oral Microbiota Dysbiosis in Inflammatory Bowel Disease: a Cross-sectional Study Using Saliva as a Diagnostic Biomarker

Acronym: MIBD

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 20, 2025
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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