Clinical trial NCT05537909: Role of Gut Microbiota in the Pathophysiology of Aseptic Abscesses
Official title: Role of Gut Microbiota in the Pathophysiology of Aseptic Abscesses
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aseptic Abscess Syndrome
Keywords: Aseptic abscess syndrome
Comparative Study
Pathophysiology
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All patients and their controls will have a sample of urine, stool, saliva and blood taken 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.
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gut microbiota profiling (diversity) of patients with aseptic abscess syndrome and matched healthy controls
timeFrame: day 1
measure: Gut microbiota profiling (composition) of patients with aseptic abscess syndrome and matched healthy controls
timeFrame: day 1
Secondary outcomes:
measure: Th17/Treg Lymphocytes phenotyping
timeFrame: day 1
measure: Salivary microbiota profiling (composition) of patients with aseptic abscess syndrome and matched healthy controls
timeFrame: day 1
measure: Salivary microbiota profiling (diversity) of patients with aseptic abscess syndrome and matched healthy controls
timeFrame: day 1
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Charleville-Mézières
country: France
facility: Centre Hospitalier Intercommunal Nord-Ardennes
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Créteil
country: France
facility: CHU Henri Mondor - Assistance Publique -Hôpitaux de Paris (AP-HP)
city: Dax
country: France
facility: Centre Hospitalier de Dax
city: Lyon
country: France
facility: Centre Hospitalier Saint Joseph Saint Luc
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Marseille
country: France
facility: Assistance Publique - Hôpitaux de Marseille (AP-HM)
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nantes
country: France
facility: CHU de Nantes
city: Nîmes
country: France
facility: CHU de Nimes
city: Paris
country: France
facility: Hôpital Cochin - Assistance Publique -Hôpitaux de Paris (AP-HP)
city: Paris
country: France
facility: Hôpital La Pitié-Salpétrière - Assistance Publique -Hôpitaux de Paris (AP-HP)
city: Paris
country: France
facility: Hôpital Louis Mourier - Assistance Publique -Hôpitaux de Paris (AP-HP)
city: Paris
country: France
facility: Hôpital Saint Louis Lariboisière - Assistance Publique -Hôpitaux de Paris (AP-HP)
Study officials:
References: