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Inflammatory Bowel Disease (IBD)MIBDNCT06980818

Oral Microbiota Dysbiosis in IBD

An observational study of Inflammatory Bowel Disease (IBD) and Dysbiosis, run by ULS Viseu Dão Lafões at 1 site in Portugal.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Inflammatory Bowel Disease (IBD), Dysbiosis
How many people
130 participants
Where
1 sitePortugal
Study dates
11 Mar 2022to 31 Dec 2025
How long will I take part?
4 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: All patients who met the inclusion criteria were followed in the IBD consultation at the Gastroenterology Department of ULS Viseu Dão-Lafões.

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Portugal1 site
  • ULS Viseu Dão-Lafões

    Viseu, Viseu District, 3504-509

Other trials in Portugal

About this study

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

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.

Read the detailed description

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.
Being tested
No intervention
Keywords
IBD, Microbiome, Saliva
Medical subject headings
Inflammatory Bowel Diseases, Dysbiosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    No intervention will take place.

Study groups in NCT06980818
Study groupRoleWhat they receive
IBD patientsPatients with Crohn's disease or ulcerative colitis
Receives: Other: No intervention
Control groupAge-matched unrelated healthy individuals
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oral microbiome characterization

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

    Measured: 3 years

Secondary outcomes (2)
  1. Bacterial species characterization in IBD

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

    Measured: 3 years

  2. Does oral microbiota correlates with disease activity?

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

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2025
  2. Study start11 Mar 2022
  3. Primary completion30 Nov 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
130 participants (estimated)
Target duration
4 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06980818
Sponsor's protocol ID
UIDP/04279/2020
Acronym
MIBD
Status last verified
Mar 2025
First submitted
26 Mar 2025
Last updated
20 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Chandan JS, Thomas T. The impact of inflammatory bowel disease on oral health. Br Dent J. 2017 Apr 7;222(7):549-553. doi: 10.1038/sj.bdj.2017.318.

    PubMed 28387295

Questions about this trial

What is this clinical trial studying?

An observational study of Inflammatory Bowel Disease (IBD) and Dysbiosis, run by ULS Viseu Dão Lafões at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oral microbiome characterization (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06980818, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.

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