Role of Gut Microbiota in the Pathophysiology of Aseptic Abscesses

Last updated: September 11, 2024
Sponsor: University Hospital, Clermont-Ferrand
Overall Status: Active - Recruiting

Phase

N/A

Condition

Soft Tissue Infections

Treatment

Biological sample collection

Clinical Study ID

NCT05537909
RBHP ANDRE (ABSCESSBIOT)
2017-A03499-44
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • For cases: adult patients meeting the diagnostic criteria for aseptic abscesssyndrome described by André et al:

  • Deep abscesses on radiological examination with neutrophilic features proven bypathological analysis of a surgical specimen or biopsy when performed

  • Negative blood cultures, negative serological tests for bacteria, including alwaysYersinia enterocolitica, and, during surgery or aspiration, sterile pus (withstandard cultures, BAAR and fungal tests) Failure of antibiotic therapy, whenprescribed, 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 (atleast 1/2 mg/kg prednisone or equivalent) followed by radiological improvement after 1 month of corticosteroids, sometimes in association with immunosuppressivetreatments.

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

Exclusion Criteria:

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

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Biological sample collection
Phase:
Study Start date:
September 07, 2021
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • CHU de Bordeaux

    Bordeaux, 33000
    France

    Active - Recruiting

  • Centre Hospitalier Intercommunal Nord-Ardennes

    Charleville-Mézières, 08011
    France

    Active - Recruiting

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63000
    France

    Active - Recruiting

  • CHU Henri Mondor - Assistance Publique -Hôpitaux de Paris (AP-HP)

    Créteil,
    France

    Active - Recruiting

  • Centre Hospitalier de Dax

    Dax, 40107
    France

    Active - Recruiting

  • Centre Hospitalier Saint Joseph Saint Luc

    Lyon, 69000
    France

    Active - Recruiting

  • Hospices Civils de Lyon

    Lyon, 69000
    France

    Active - Recruiting

  • Assistance Publique - Hôpitaux de Marseille (AP-HM)

    Marseille, 13000
    France

    Active - Recruiting

  • CHU de Montpellier

    Montpellier, 34000
    France

    Active - Recruiting

  • CHU de Nantes

    Nantes, 44093
    France

    Active - Recruiting

  • CHU de Nimes

    Nîmes, 30029
    France

    Active - Recruiting

  • Hôpital Cochin - Assistance Publique -Hôpitaux de Paris (AP-HP)

    Paris,
    France

    Active - Recruiting

  • Hôpital La Pitié-Salpétrière - Assistance Publique -Hôpitaux de Paris (AP-HP)

    Paris,
    France

    Active - Recruiting

  • Hôpital Louis Mourier - Assistance Publique -Hôpitaux de Paris (AP-HP)

    Paris,
    France

    Active - Recruiting

  • Hôpital Saint Louis Lariboisière - Assistance Publique -Hôpitaux de Paris (AP-HP)

    Paris,
    France

    Active - Recruiting

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