Role of Gut Microbiota in the Pathophysiology of Aseptic Abscesses
NCT ID: NCT05537909
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2021-09-07
2025-12-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Patients
adult patients with aseptic abscess syndrome
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.
control
control An adult person living in the same environment as the case.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Locations
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CHU de Bordeaux
Bordeaux, , France
Centre Hospitalier Intercommunal Nord-Ardennes
Charleville-Mézières, , France
CHU de Clermont-Ferrand
Clermont-Ferrand, , France
CHU Henri Mondor - Assistance Publique -Hôpitaux de Paris (AP-HP)
Créteil, , France
Centre Hospitalier de Dax
Dax, , France
Centre Hospitalier Saint Joseph Saint Luc
Lyon, , France
Hospices Civils de Lyon
Lyon, , France
Assistance Publique - Hôpitaux de Marseille (AP-HM)
Marseille, , France
CHU de Montpellier
Montpellier, , France
CHU de Nantes
Nantes, , France
CHU de Nimes
Nîmes, , France
Hôpital Cochin - Assistance Publique -Hôpitaux de Paris (AP-HP)
Paris, , France
Hôpital La Pitié-Salpétrière - Assistance Publique -Hôpitaux de Paris (AP-HP)
Paris, , France
Hôpital Louis Mourier - Assistance Publique -Hôpitaux de Paris (AP-HP)
Paris, , France
Hôpital Saint Louis Lariboisière - Assistance Publique -Hôpitaux de Paris (AP-HP)
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Trefond L, Billard E, Pereira B, Richard D, Vazeille E, Bonnet R, Barnich N, Andre M; Aseptic Abscess Syndrome physicians. Host-microbiota relationship in the pathophysiology of aseptic abscess syndrome: protocol for a multicentre case-control study (ABSCESSBIOT). BMJ Open. 2023 Aug 4;13(8):e073776. doi: 10.1136/bmjopen-2023-073776.
Other Identifiers
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2017-A03499-44
Identifier Type: OTHER
Identifier Source: secondary_id
RBHP ANDRE (ABSCESSBIOT)
Identifier Type: -
Identifier Source: org_study_id
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