Role of Gut Microbiota in the Pathophysiology of Aseptic Abscesses

NCT05537909 | Recruiting

• 2 other identifiers: RBHP ANDRE (ABSCESSBIOT)2017-A03499-44
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 15

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.

Conditions

Aseptic Abscess Syndrome

Keywords

Aseptic abscess syndrome; Comparative Study; Pathophysiology

Outcome Measures

Primary Outcomes (2)

• Gut microbiota profiling (diversity) of patients with aseptic abscess syndrome and matched healthy controls

  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

  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 Outcomes (3)

• Th17/Treg Lymphocytes phenotyping

  day 1

• Salivary microbiota profiling (composition) of 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

  day 1

Study Arms (2)

Patients

EXPERIMENTAL

adult patients with aseptic abscess syndrome

Other: Biological sample collection

control

EXPERIMENTAL

control An adult person living in the same environment as the case.

Other: Biological sample collection

Interventions

Biological sample collection 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.

Patients; control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (15)

CHU de Bordeaux

Bordeaux, 33000, France

RECRUITING

Centre Hospitalier Intercommunal Nord-Ardennes

Charleville-Mézières, 08011, France

RECRUITING

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

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

Créteil, France

RECRUITING

Centre Hospitalier de Dax

Dax, 40107, France

RECRUITING

Centre Hospitalier Saint Joseph Saint Luc

Lyon, 69000, France

RECRUITING

Hospices Civils de Lyon

Lyon, 69000, France

RECRUITING

Assistance Publique - Hôpitaux de Marseille (AP-HM)

Marseille, 13000, France

RECRUITING

CHU de Montpellier

Montpellier, 34000, France

RECRUITING

CHU de Nantes

Nantes, 44093, France

RECRUITING

CHU de Nimes

Nîmes, 30029, France

RECRUITING

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

Paris, France

RECRUITING

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

Paris, France

RECRUITING

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

Paris, France

RECRUITING

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

Paris, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 37541750 DERIVED

Central Study Contacts

Lise Laclautre, PharmD

CONTACT

04 73 754 963; promo_interne_drci@chu-clermontferrand.fr

Trefond Ludovic, MD

CONTACT

promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: September 13, 2022
• Study Start: September 7, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (15)