Non-Alcoholic Fatty Liver DiseaseBUCCONAFLDNCT05654129
Porphyromonas Gingivalis and Severity of Fibrosis in Patients With Non-alcoholic Fatty Liver Disease
A study testing saliva samples and medical questionnaire in people with Non-Alcoholic Fatty Liver Disease, run by University Hospital, Toulouse at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- saliva samples and medical questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteFrance
- Study dates
- 5 Dec 2022to 5 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
Cathy Nabet contact
France1 site, 1 recruiting
- Recruiting
CHU Toulouse
Toulouse, 31059
Vincent BLASCO-BAQUE, 0675188124 ext. +33, blasco-baque.v@chu-toulouse.fr
About this study
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)
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.
Read the 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.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- saliva samples, medical questionnaire
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saliva samplesOther
saliva samples (non-invasive, in the sites evaluated during the partial survey) will be perform by one of the investigators .
medical questionnaireOther
a complete medical questionnaire will be carried out (general, lifestyle and quality of life) will be perform by one of the investigators .
| Study group | Role | What they receive |
|---|---|---|
| F1-F2 NAFLD | Other | Patients with NAFLD stage 1 or 2 confirmed by a biopsy less than 1 year old Receives: 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 Receives: Other: saliva samples; Other: medical questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start5 Dec 2022
- Primary completion5 Dec 2022
- Study completion5 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- people with stage F1-F2 NAFLD versus people with stage F3-F4
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent BLASCO-BAQUE, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654129
- Sponsor's protocol ID
- RC31/19/0043
- Acronym
- BUCCONAFLD
- Status last verified
- Dec 2022
- First submitted
- 8 Dec 2022
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05654129
- Acronym / sponsor ID
- BUCCONAFLD / RC31/19/0043
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 5 Dec 2023 (estimated)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- people with stage F1-F2 NAFLD versus people with stage F3-F4
| Arm | Type | Receives |
|---|---|---|
| F1-F2 NAFLD | Other | Other: saliva samples, Other: medical questionnairePatients with NAFLD stage 1 or 2 confirmed by a biopsy less than 1 year old |
| F3-F4 NAFLD | Other | Other: saliva samples, Other: medical questionnairePatients with NAFLD stage 3 or 4 confirmed by a biopsy less than 1 year old |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| saliva samplessaliva samples (non-invasive, in the sites evaluated during the partial survey) will be perform by one of the investigators . | Other | F1-F2 NAFLD, F3-F4 NAFLD |
| medical questionnairea complete medical questionnaire will be carried out (general, lifestyle and quality of life) will be perform by one of the investigators . | Other | F1-F2 NAFLD, F3-F4 NAFLD |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Non-Alcoholic Fatty Liver Disease
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cathy Nabet contact
Vincent BLASCO-BAQUE principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing saliva samples and medical questionnaire in people with Non-Alcoholic Fatty Liver Disease, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincent BLASCO-BAQUE (0675188124 ext. +33, blasco-baque.v@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of Porphyromonas gingivalis in the saliva (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2022.