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Role of Gut Microbiota in the Pathophysiology of Aseptic Abscesses

Role of Gut Microbiota in the Pathophysiology of Aseptic Abscesses

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05537909
Acronym
ABSCESSBIOT
Enrollment
60
Registered
2022-09-13
Start date
2021-09-07
Completion date
2025-12-31
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aseptic Abscess Syndrome

Keywords

Aseptic abscess syndrome, Comparative Study, Pathophysiology

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.

Interventions

OTHERBiological 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.

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Gut microbiota profiling (diversity) of patients with aseptic abscess syndrome and matched healthy controlsday 116S 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.
Gut microbiota profiling (composition) of patients with aseptic abscess syndrome and matched healthy controlsday 116S 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.

Secondary

MeasureTime frameDescription
Th17/Treg Lymphocytes phenotypingday 1Th17/Treg Lymphocytes phenotyping of patients with aseptic abscesses compared to matched healthy controls.
Salivary microbiota profiling (composition) of patients with aseptic abscess syndrome and matched healthy controlsday 116S 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.
Salivary microbiota profiling (diversity) of patients with aseptic abscess syndrome and matched healthy controlsday 116S 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.

Countries

France

Contacts

Primary ContactLise Laclautre, PharmD
promo_interne_drci@chu-clermontferrand.fr04 73 754 963
Backup ContactTrefond Ludovic, MD
promo_interne_drci@chu-clermontferrand.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026