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Search / Trial NCT05654129

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

Launched by UNIVERSITY HOSPITAL, TOULOUSE · Dec 8, 2022

Trial Information

Current as of February 05, 2025

Unknown status

Keywords

ClinConnect Summary

This clinical trial is investigating the role of a specific bacteria called Porphyromonas gingivalis in worsening non-alcoholic fatty liver disease (NAFLD). This condition occurs when fat builds up in the liver without heavy alcohol use, leading to inflammation and potential liver damage. Researchers want to understand if this bacteria contributes to increased inflammation in the liver, which could help develop better treatments for people with NAFLD.

To participate in the study, individuals must be over 18 years old and have a recent biopsy confirming they have NAFLD. They should also be able to understand the study details and willingly agree to take part. However, those with other liver diseases, significant alcohol consumption, or certain recent medical treatments may not be eligible. Participants can expect to undergo assessments related to their liver health and how the bacteria may affect their condition. This study is currently recruiting and aims to gather valuable information to improve care for patients with non-alcoholic fatty liver disease.

Gender

ALL

Eligibility criteria

  • 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

Trial Officials

Vincent BLASCO-BAQUE

Principal Investigator

University Hospital, Toulouse

About University Hospital, Toulouse

The University Hospital of Toulouse is a leading academic medical center dedicated to advancing healthcare through innovative research and clinical trials. With a strong emphasis on patient-centered care, the hospital integrates cutting-edge scientific inquiry with comprehensive clinical services. Its multidisciplinary team of healthcare professionals collaborates with renowned researchers to facilitate pioneering studies across various medical fields, aiming to enhance treatment options and improve patient outcomes. As a prominent institution in the region, the University Hospital of Toulouse is committed to fostering an environment of excellence in both education and research within the healthcare community.

Locations

Toulouse, , France

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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