Role of Gut Microbiota in the Pathophysiology of Aseptic Abscesses

Not Applicable

Recruiting

• Conditions: Aseptic Abscess Syndrome
• Interventions: Other: Biological sample collection

• Registration Number: NCT05537909
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study Start: 2021-09-07
• Primary Completion: 2021-09-07
• Study First Submitted: 2022-06-17
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-08
• Study First Posted: 2022-09-13
• Last Update Submitted: 2022-09-15
• Last Update Posted: 2022-09-19
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients	Biological sample collection	adult patients with aseptic abscess syndrome
control	Biological sample collection	control An adult person living in the same environment as the case.

Primary Outcome Measures

Name	Time	Method
Gut microbiota profiling (composition) of patients with aseptic abscess syndrome and matched healthy controls	day 1	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.
Gut microbiota profiling (diversity) of patients with aseptic abscess syndrome and matched healthy controls	day 1	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.

Secondary Outcome Measures

Name	Time	Method
Th17/Treg Lymphocytes phenotyping	day 1	Th17/Treg Lymphocytes phenotyping of patients with aseptic abscesses compared to matched healthy controls.
Salivary microbiota profiling (diversity) of patients with aseptic abscess syndrome and matched healthy controls	day 1	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.
Salivary microbiota profiling (composition) of patients with aseptic abscess syndrome and matched healthy controls	day 1	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.

Trial Locations

Locations (15)

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

Centre Hospitalier Intercommunal Nord-Ardennes; 🇫🇷 Charleville-Mézières, France

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

CHU de Montpellier; 🇫🇷 Montpellier, France

Hôpital Saint Louis Lariboisière - Assistance Publique -Hôpitaux de Paris (AP-HP); 🇫🇷 Paris, France

CHU de Bordeaux; 🇫🇷 Bordeaux, France

Hospices Civils de Lyon; 🇫🇷 Lyon, France

Hôpital Cochin - Assistance Publique -Hôpitaux de Paris (AP-HP); 🇫🇷 Paris, France

Assistance Publique - Hôpitaux de Marseille (AP-HM); 🇫🇷 Marseille, France

CHU de Nantes; 🇫🇷 Nantes, France

CHU de Nimes; 🇫🇷 Nîmes, 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