Porphyromonas Gingivalis and Severity of Fibrosis in Patients With Non-alcoholic Fatty Liver Disease (BUCCONAFLD)

Non-interventional Study Exploring the Relationship Between Porphyromonas Gingivalis and the Severity of Fibrosis in Patients With Non-alcoholic Fatty Liver Disease (NAFLD)

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.

Study Overview

• Status: Recruiting
• Conditions: Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Other: saliva samples; Other: medical questionnaire

Detailed Description

Non-alcoholic fatty liver disease is becoming the leading cause of chronic liver disease with a prevalence of 20% worldwide. The prognosis depends on the degree of fibrosis: patients with a low degree of fibrosis (F0-F2) have a good prognosis unlike those with severe fibrosis or cirrhosis (F3-F4), exposed to excess mortality from cardiovascular diseases , cancers, and complications of cirrhosis. The diagnosis of the fibrosis stage is histological but the worsening of the fibrosis remains unknown.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 182
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vincent BLASCO-BAQUE; Phone Number: +33 0675188124; Email: blasco-baque.v@chu-toulouse.fr
• Study Contact Backup: Name: Cathy Nabet; Email: catherine.nabet@univ-tlse3.fr

Study Locations

• France
  • Toulouse, France, 31059
    • Recruiting
    • CHU Toulouse
    • Contact: Vincent BLASCO-BAQUE; Phone Number: +33 0675188124; Email: blasco-baque.v@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• subjects with NAFLD confirmed by a biopsy less than 1 year old
• 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:

• Having another associated cause of liver disease or steatosis such as viral infections and autoimmune disease
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: F1-F2 NAFLD; Patients with NAFLD stage 1 or 2 confirmed by a biopsy less than 1 year old	Other: saliva samples; saliva samples (non-invasive, in the sites evaluated during the partial survey) will be perform by one of the investigators .; Other: medical questionnaire; a complete medical questionnaire will be carried out (general, lifestyle and quality of life) will be perform by one of the investigators .
Other: F3-F4 NAFLD; Patients with NAFLD stage 3 or 4 confirmed by a biopsy less than 1 year old	Other: saliva samples; saliva samples (non-invasive, in the sites evaluated during the partial survey) will be perform by one of the investigators .; Other: medical questionnaire; a complete medical questionnaire will be carried out (general, lifestyle and quality of life) will be perform by one of the investigators .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
frequency of Porphyromonas gingivalis in the saliva	compare the mean frequency of Porphyromonas gingivalis in the saliva of people with stage F1-F2 NAFLD versus people with stage F3-F4.	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Vincent BLASCO-BAQUE, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2022
• Primary Completion (Actual): December 5, 2022
• Study Completion (Anticipated): December 5, 2023

Study Registration Dates

• First Submitted: December 8, 2022
• First Submitted That Met QC Criteria: December 8, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Actual): December 16, 2022
• Last Update Submitted That Met QC Criteria: December 8, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: RC31/19/0043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No