Role of Gut Microbiota in the Pathophysiology of Aseptic Abscesses (ABSCESSBIOT)

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.

Study Overview

• Status: Recruiting
• Conditions: Aseptic Abscess Syndrome
• Intervention / Treatment: Other: Biological sample collection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Trefond Ludovic, MD; Email: promo_interne_drci@chu-clermontferrand.fr

Study Locations

• France
  • Bordeaux, France, 33000
    • Recruiting
    • CHU de Bordeaux
    • Contact: Lise Laclautre, PharmD; Phone Number: 04 73 754 963; Email: promo_interne_drci@chu-clermontferrand.fr
    • Principal Investigator: Jean-François Viallard, MD
    • Principal Investigator: Fabrice BONNET, MD
  • Charleville-Mézières, France, 08011
    • Recruiting
    • Centre Hospitalier Intercommunal Nord-Ardennes
    • Principal Investigator: Jean-Michel GALEMPOIX, MD
  • Clermont-Ferrand, France, 63000
    • Recruiting
    • CHU de Clermont-Ferrand
    • Contact: Lise Laclautre, Pharm D; Phone Number: 33 04 73 754 963; Email: promo_interne_drci@chu-clermontferrand.fr
    • Sub-Investigator: Ludovic TREFOND, MD
    • Principal Investigator: Olivier AUMAITRE, MD
  • Créteil, France
    • Recruiting
    • CHU Henri Mondor - Assistance Publique -Hôpitaux de Paris (AP-HP)
    • Principal Investigator: Olivier CHOSIDOW, MD
  • Dax, France, 40107
    • Recruiting
    • Centre Hospitalier de Dax
    • Principal Investigator: François LIFERMANN, MD
  • Lyon, France, 69000
    • Recruiting
    • Centre Hospitalier Saint Joseph Saint Luc
  • Lyon, France, 69000
    • Recruiting
    • Hospices Civils de Lyon
    • Principal Investigator: Hélène DESMURS-CLAVEL, MD
  • Marseille, France, 13000
    • Recruiting
    • Assistance Publique - Hôpitaux de Marseille (AP-HM)
    • Principal Investigator: Laure SWIADER, MD
  • Montpellier, France, 34000
    • Recruiting
    • CHU de Montpellier
    • Contact: Lise Laclautre, PharmD; Phone Number: 04 73 754 963; Email: promo_interne_drci@chu-clermontferrand.fr
  • Nantes, France, 44093
    • Recruiting
    • CHU de Nantes
    • Contact: Lise Laclautre, PharmD; Phone Number: 33 04 73 754 730; Email: promo_interne_drci@chu-clermontferrand.fr
    • Principal Investigator: Jérôme CONNAULT, MD
  • Nîmes, France, 30029
    • Recruiting
    • CHU de Nîmes
    • Principal Investigator: Jean-François BOURGAUX, MD
  • Paris, France
    • Recruiting
    • Hôpital Cochin - Assistance Publique -Hôpitaux de Paris (AP-HP)
    • Contact: Lise Laclautre, PharmD; Phone Number: 04 73 754 730; Email: promo-interne-drci@chu-clermontferrand.fr
    • Principal Investigator: Nathalie COSTEDOAT-CHALUMEAU, MD
  • Paris, France
    • Recruiting
    • Hôpital La Pitié-Salpétrière - Assistance Publique -Hôpitaux de Paris (AP-HP)
    • Contact: Lise Laclautre, PharmD; Phone Number: 04 73 754 730; Email: promo_interne_drci@chu-clermontferrand.fr
    • Principal Investigator: Jean-Charles PIETTE, MD
  • Paris, France
    • Recruiting
    • Hôpital Louis Mourier - Assistance Publique -Hôpitaux de Paris (AP-HP)
    • Principal Investigator: Elisabeth ASLANGUL, MD
  • Paris, France
    • Recruiting
    • Hôpital Saint Louis Lariboisière - Assistance Publique -Hôpitaux de Paris (AP-HP)
    • Contact: Lise Laclautre, PharmD; Phone Number: 33 04 73 754 730; Email: promo_interne_drci@chu-clermontferrand.fr
    • Principal Investigator: Clémence LEPELLETIER, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients; adult patients with aseptic abscess syndrome	Other: 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.
Experimental: control; control An adult person living in the same environment as the case.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Th17/Treg Lymphocytes phenotyping	Th17/Treg Lymphocytes phenotyping of patients with aseptic abscesses compared to matched healthy controls.	day 1
Salivary 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 salivary microbiota composition between 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	16S rRNA gene sequencing technique and illumina MiSeq platform to investigate the difference of salivary microbiota diversity between patients with aseptic abscess syndrome and matched healthy controls.	day 1

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2021
• Primary Completion (Actual): September 7, 2021
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: June 17, 2022
• First Submitted That Met QC Criteria: September 8, 2022
• First Posted (Actual): September 13, 2022

Study Record Updates

• Last Update Posted (Actual): September 19, 2022
• Last Update Submitted That Met QC Criteria: September 15, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Pathophysiology; Comparative Study; Aseptic abscess syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Suppuration; Abscess
• Other Study ID Numbers: RBHP ANDRE (ABSCESSBIOT); 2017-A03499-44 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No