Porphyromonas Gingivalis and Severity of Fibrosis in Patients With Non-alcoholic Fatty Liver Disease
NCT ID: NCT05654129
Last Updated: 2022-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
182 participants
INTERVENTIONAL
2022-12-05
2023-12-05
Brief Summary
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Detailed Description
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The intestinal microbiota is an etiological factor in NAFLD and dysbiosis is associated with the severity of fibrosis. There is also a physiopathological rationale between oral bacterial microbiota and NAFLD. The oral microbiota is very rich, it corresponds to a reservoir of 1010 bacteria of Gram-negative bacteria (BGN). Its dysbiosis causes oral infections like periodontal diseases, immuno-infectious pathologies linked to an imbalance between the bacterial etiological factor and the host's immune defenses.
Many studies suggest that Porphyromonas gingivalis, a virulent periodontopathogenic bacterium, is associated with many systemic diseases such as cardiovascular diseases. In addition, a recent study showed the impact of Porphyromonas gingivalis on Non-Alcoholic Steatosis Liver Disease (NASH). It would be responsible for aggravation of non-alcoholic fatty liver disease (NAFLD) by stimulating inflammation in the damaged liver tissue.
the hypothesis that the salivary levels of Porphyromonas Gingivalis could be associated with the degree of severity of fibrosis in NAFLD patients, and would constitute a new therapeutic target for the evaluation of fibrosis. This work would open new perspectives in treatment strategies.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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F1-F2 NAFLD
Patients with NAFLD stage 1 or 2 confirmed by a biopsy less than 1 year old
saliva samples
saliva samples (non-invasive, in the sites evaluated during the partial survey) will be perform by one of the investigators .
medical questionnaire
a complete medical questionnaire will be carried out (general, lifestyle and quality of life) will be perform by one of the investigators .
F3-F4 NAFLD
Patients with NAFLD stage 3 or 4 confirmed by a biopsy less than 1 year old
saliva samples
saliva samples (non-invasive, in the sites evaluated during the partial survey) will be perform by one of the investigators .
medical questionnaire
a complete medical questionnaire will be carried out (general, lifestyle and quality of life) will be perform by one of the investigators .
Interventions
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saliva samples
saliva samples (non-invasive, in the sites evaluated during the partial survey) will be perform by one of the investigators .
medical questionnaire
a complete medical questionnaire will be carried out (general, lifestyle and quality of life) will be perform by one of the investigators .
Eligibility Criteria
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Inclusion Criteria
* subjects over the age of 18
* subjects able to receive information on the course of the study and to understand the information form to participate in the study
* the subjects who gave their non-objection to participate in the study
Exclusion Criteria
* With alcohol consumption \>30g/d (men) or 20g/d (women)
* With a history of cirrhosis decompensation
* Having taken antibiotics, prebiotics or probiotics in the month prior to inclusion
* With chronic or acute gastrointestinal disease
* With a history of gastrointestinal surgery modifying the anatomy
* During pregnancy or breastfeeding
* With a history of oral surgery in the month prior to inclusion
* For whom oral surgery is planned between the collection of the non-objection and the inclusion in the odontology service
* At risk of infection (existence of one or more known chronic infectious pathologies) and/or chronic renal failure (creatinine clearance \< 60ml/min).
* Suffering from a general pathology contraindicating the performance of diagnostic procedures such as periodontal probing (patients at high risk of infective endocarditis according to the French National Agency for the Safety of Medicines and Health Products ANSM)
* Under legal protection, dependent, under guardianship or curatorship
18 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Vincent BLASCO-BAQUE
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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CHU Toulouse
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Vincent BLASCO-BAQUE
Role: primary
Other Identifiers
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RC31/19/0043
Identifier Type: -
Identifier Source: org_study_id