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

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ClinicalTrials.gov Identifier: NCT05654129
Recruitment Status : Recruiting
First Posted : December 16, 2022
Last Update Posted : December 16, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Other: saliva samples Other: medical questionnaire Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 182 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: people with stage F1-F2 NAFLD versus people with stage F3-F4
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Non-interventional Study Exploring the Relationship Between Porphyromonas Gingivalis and the Severity of Fibrosis in Patients With Non-alcoholic Fatty Liver Disease (NAFLD)
Actual Study Start Date : December 5, 2022
Actual Primary Completion Date : December 5, 2022
Estimated Study Completion Date : December 5, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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 .
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 .


Outcome Measures
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Primary Outcome Measures :
  1. frequency of Porphyromonas gingivalis in the saliva [ Time Frame: 1 day ]
    compare the mean frequency of Porphyromonas gingivalis in the saliva of people with stage F1-F2 NAFLD versus people with stage F3-F4.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05654129


Contacts
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Contact: Vincent BLASCO-BAQUE 0675188124 ext +33 blasco-baque.v@chu-toulouse.fr
Contact: Cathy Nabet catherine.nabet@univ-tlse3.fr

Locations
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France
CHU Toulouse Recruiting
Toulouse, France, 31059
Contact: Vincent BLASCO-BAQUE    0675188124 ext +33    blasco-baque.v@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Vincent BLASCO-BAQUE University Hospital, Toulouse
More Information
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT05654129    
Other Study ID Numbers: RC31/19/0043
First Posted: December 16, 2022    Key Record Dates
Last Update Posted: December 16, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases