Role of Gut Microbiota in the Pathophysiology of Aseptic Abscesses

NCT ID: NCT05537909

Last Updated: 2024-09-19

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-07

Study Completion Date

2025-12-31

Brief Summary

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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

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* 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.

Conditions

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Aseptic Abscess Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients

adult patients with aseptic abscess syndrome

Group Type EXPERIMENTAL

Biological sample collection

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Biological sample collection

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Bordeaux

Bordeaux, , France

Site Status RECRUITING

Centre Hospitalier Intercommunal Nord-Ardennes

Charleville-Mézières, , France

Site Status RECRUITING

CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

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

Créteil, , France

Site Status RECRUITING

Centre Hospitalier de Dax

Dax, , France

Site Status RECRUITING

Centre Hospitalier Saint Joseph Saint Luc

Lyon, , France

Site Status RECRUITING

Hospices Civils de Lyon

Lyon, , France

Site Status RECRUITING

Assistance Publique - Hôpitaux de Marseille (AP-HM)

Marseille, , France

Site Status RECRUITING

CHU de Montpellier

Montpellier, , France

Site Status RECRUITING

CHU de Nantes

Nantes, , France

Site Status RECRUITING

CHU de Nimes

Nîmes, , France

Site Status RECRUITING

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

Paris, , France

Site Status RECRUITING

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

Paris, , France

Site Status RECRUITING

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

Paris, , France

Site Status RECRUITING

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

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Lise Laclautre, PharmD

Role: CONTACT

04 73 754 963 ext. 33

Trefond Ludovic, MD

Role: CONTACT

Facility Contacts

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Lise Laclautre, PharmD

Role: primary

04 73 754 963

Lise Laclautre, PharmD

Role: primary

04 73 754 963 ext. 33

Lise Laclautre, Pharm D

Role: primary

04 73 754 963 ext. 33

Lise Laclautre, PharmD

Role: primary

04 73 754 963 ext. 33

Lise Laclautre, PharmD

Role: primary

04 73 754 963 ext. 33

Lise Laclautre, PharmD

Role: primary

04 73 754 963 ext. 33

Lise Laclautre, PharmD

Role: primary

04 73 754 963 ext. 33

Lise Laclautre, PharmD

Role: primary

04 73 754 963 ext. 33

Lise Laclautre, PharmD

Role: primary

04 73 754 963

Lise Laclautre, PharmD

Role: primary

04 73 754 730 ext. 33

Lise Laclautre, PharmD

Role: primary

04 73 754 963 ext. 33

Lise Laclautre, PharmD

Role: primary

04 73 754 730

Lise Laclautre, PharmD

Role: primary

04 73 754 730

Lise Laclautre, PharmD

Role: primary

04 73 754 963 ext. 33

Lise Laclautre, PharmD

Role: primary

04 73 754 730 ext. 33

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.

Reference Type DERIVED
PMID: 37541750 (View on PubMed)

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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