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

NCT05654129 | Unknown

• 1 other identifier: RC31/19/0043
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

F1-F2 NAFLD

OTHER

Patients with NAFLD stage 1 or 2 confirmed by a biopsy less than 1 year old

Other: saliva samples; Other: medical questionnaire

F3-F4 NAFLD

OTHER

Patients with NAFLD stage 3 or 4 confirmed by a biopsy less than 1 year old

Other: saliva samples; Other: medical questionnaire

Interventions

saliva samples OTHER

saliva samples (non-invasive, in the sites evaluated during the partial survey) will be perform by one of the investigators .

F1-F2 NAFLD; F3-F4 NAFLD

medical questionnaire OTHER

a complete medical questionnaire will be carried out (general, lifestyle and quality of life) will be perform by one of the investigators .

F1-F2 NAFLD; F3-F4 NAFLD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• With chronic or acute gastrointestinal disease
• With a history of gastrointestinal surgery modifying the anatomy
• During pregnancy or breastfeeding
• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU Toulouse

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Vincent BLASCO-BAQUE

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent BLASCO-BAQUE

CONTACT

0675188124; blasco-baque.v@chu-toulouse.fr

Cathy Nabet

CONTACT

catherine.nabet@univ-tlse3.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: people with stage F1-F2 NAFLD versus people with stage F3-F4

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 16, 2022
• Study Start: December 5, 2022
• Primary Completion: December 5, 2022
• Study Completion: December 5, 2023
• Last Updated: December 16, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)