Role of Gut Microbiota in the Pathophysiology of Aseptic Abscesses (ABSCESSBIOT)

September 11, 2024 updated by: University Hospital, Clermont-Ferrand

Aseptic abscess syndrome (AA) is a rare entity characterized by the occurrence of deep abscesses with no germ found. Antibiotic therapy is ineffective and they are sensitive to anti-inflammatory treatment with corticosteroids.

Gut microbiota is important for the development of the immune system. In Crohn's disease which is frequently associated with AA syndrome, dysbiosis is found but could also be involved in the immune response at a distance from the gut.

Stool, blood, saliva and urine samples will be taken from the patients included and their controls in the centers where they are followed. These biological samples will be transported to Clermont Ferrand using the same procedure (transporter and dry ice) where the following analyses will be performed: microbiota on stool and saliva, short chain fatty acids on stool and lymphocyte study on blood.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  • Included patients will be adult patients meeting the diagnostic criteria for aseptic abscess syndrome described by André et al.
  • Controls will be adults without aseptic abscess syndrome living in the same environment as the patients, whether related to the patient or not.

Patients and controls must be able to provide informed consent and be affiliated with the French Social Security system.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France, 33000
        • Recruiting
        • CHU de Bordeaux
        • Contact:
        • Principal Investigator:
          • Jean-François Viallard, MD
        • Principal Investigator:
          • Fabrice BONNET, MD
      • Charleville-Mézières, France, 08011
        • Recruiting
        • Centre Hospitalier Intercommunal Nord-Ardennes
        • Principal Investigator:
          • Jean-Michel GALEMPOIX, MD
        • Contact:
      • Clermont-Ferrand, France, 63000
        • Recruiting
        • CHU de Clermont-Ferrand
        • Contact:
        • Sub-Investigator:
          • Ludovic TREFOND, MD
        • Principal Investigator:
          • Olivier AUMAITRE, MD
        • Principal Investigator:
          • Marc ANDRE, MD
      • Créteil, France
        • Recruiting
        • CHU Henri Mondor - Assistance Publique -Hôpitaux de Paris (AP-HP)
        • Principal Investigator:
          • Olivier CHOSIDOW, MD
        • Contact:
      • Dax, France, 40107
      • Lyon, France, 69000
      • Lyon, France, 69000
      • Marseille, France, 13000
        • Recruiting
        • Assistance Publique - Hôpitaux de Marseille (AP-HM)
        • Principal Investigator:
          • Laure SWIADER, MD
        • Contact:
      • Montpellier, France, 34000
      • Nantes, France, 44093
      • Nîmes, France, 30029
      • Paris, France
        • Recruiting
        • Hôpital Cochin - Assistance Publique -Hôpitaux de Paris (AP-HP)
        • Contact:
        • Principal Investigator:
          • Nathalie COSTEDOAT-CHALUMEAU, MD
      • Paris, France
        • Recruiting
        • Hôpital La Pitié-Salpétrière - Assistance Publique -Hôpitaux de Paris (AP-HP)
        • Contact:
        • Principal Investigator:
          • Jean-Charles PIETTE, MD
      • Paris, France
        • Recruiting
        • Hôpital Louis Mourier - Assistance Publique -Hôpitaux de Paris (AP-HP)
        • Principal Investigator:
          • Elisabeth ASLANGUL, MD
        • Contact:
      • Paris, France
        • Recruiting
        • Hôpital Saint Louis Lariboisière - Assistance Publique -Hôpitaux de Paris (AP-HP)
        • Contact:
        • Principal Investigator:
          • Clémence LEPELLETIER, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • For cases: adult patients meeting the diagnostic criteria for aseptic abscess syndrome described by André et al:
  • Deep abscesses on radiological examination with neutrophilic features proven by pathological analysis of a surgical specimen or biopsy when performed
  • Negative blood cultures, negative serological tests for bacteria, including always Yersinia enterocolitica, and, during surgery or aspiration, sterile pus (with standard cultures, BAAR and fungal tests) Failure of antibiotic therapy, when prescribed, after at least 2 weeks for conventional antibiotic therapy and at least 3 months for anti-tuberculosis treatment
  • Rapid clinical improvement the day after the prescription of corticosteroids (at least 1/2 mg/kg prednisone or equivalent) followed by radiological improvement after 1 month of corticosteroids, sometimes in association with immunosuppressive treatments.

For controls: adult person living in the same environment as the case to which it is matched. Adult person living in the same household or near the patient.

For cases and controls:

  • Ability to provide informed consent.
  • Membership in the Social Security system.

Exclusion Criteria:

  • Pregnant women. Incapable patients Patients deprived of liberty Antibiotic therapy administered within 6 weeks prior to inclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients
adult patients with aseptic abscess syndrome
Other: Biological sample collection
All patients and their controls will be asked to provide a urine, stool, saliva and blood sample during a follow-up visit. Patients will not be specifically asked to take these samples, they will be taken during a follow-up visit, during which these samples are usually already taken.
Experimental: control
control An adult person living in the same environment as the case.
Other: Biological sample collection
All patients and their controls will be asked to provide a urine, stool, saliva and blood sample during a follow-up visit. Patients will not be specifically asked to take these samples, they will be taken during a follow-up visit, during which these samples are usually already taken.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut microbiota profiling (diversity) of patients with aseptic abscess syndrome and matched healthy controls
Time Frame: day 1
16S rRNA gene sequencing technique and illumina MiSeq platform to investigate the difference of gut microbiota composition between patients with aseptic abscess syndrome and matched healthy controls.
day 1
Gut microbiota profiling (composition) of patients with aseptic abscess syndrome and matched healthy controls
Time Frame: day 1
16S rRNA gene sequencing technique and illumina MiSeq platform to investigate the difference of gut microbiota diversity between patients with aseptic abscess syndrome and matched healthy controls.
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Th17/Treg Lymphocytes phenotyping
Time Frame: day 1
Th17/Treg Lymphocytes phenotyping of patients with aseptic abscesses compared to matched healthy controls.
day 1
Salivary microbiota profiling (composition) of patients with aseptic abscess syndrome and matched healthy controls
Time Frame: day 1
16S rRNA gene sequencing technique and illumina MiSeq platform to investigate the difference of salivary microbiota composition between patients with aseptic abscess syndrome and matched healthy controls.
day 1
Salivary microbiota profiling (diversity) of patients with aseptic abscess syndrome and matched healthy controls
Time Frame: day 1
16S rRNA gene sequencing technique and illumina MiSeq platform to investigate the difference of salivary microbiota diversity between patients with aseptic abscess syndrome and matched healthy controls.
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

June 17, 2022

First Submitted That Met QC Criteria

September 8, 2022

First Posted (Actual)

September 13, 2022

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 11, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBHP ANDRE (ABSCESSBIOT)
  • 2017-A03499-44 (Other Identifier: ANSM)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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