Investigating the role of gut bacteria in aseptic abscesses
Role of Gut Microbiota in the Pathophysiology of Aseptic Abscesses
This study is trying to see if the bacteria in the gut play a role in causing aseptic abscesses by comparing samples from patients with the condition to those without it.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Drugs / interventions | prednisone |
| Locations | 15 sites (Bordeaux and 14 other locations) |
| Trial ID | NCT05537909 on ClinicalTrials.gov |
What this trial studies
This study examines the relationship between gut microbiota and aseptic abscess syndrome, a condition characterized by deep abscesses without identifiable pathogens. It involves collecting biological samples such as stool, blood, saliva, and urine from patients diagnosed with the syndrome and matched controls. The samples will be analyzed to understand the microbiota composition and immune responses related to the condition. The goal is to uncover potential links between gut health and the pathophysiology of aseptic abscesses.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with aseptic abscess syndrome who meet specific clinical criteria.
Not a fit: Patients with other types of abscesses or those not meeting the diagnostic criteria for aseptic abscess syndrome may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment options for patients suffering from aseptic abscess syndrome.
How similar studies have performed: While the role of gut microbiota in various conditions has been studied, this specific investigation into aseptic abscess syndrome is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bordeaux and 14 other locations
- CHU de Bordeaux — Bordeaux, France (Recruiting)
- Centre Hospitalier Intercommunal Nord-Ardennes — Charleville-Mézières, France (Recruiting)
- CHU de Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
- CHU Henri Mondor - Assistance Publique -Hôpitaux de Paris (AP-HP) — Créteil, France (Recruiting)
- Centre Hospitalier de Dax — Dax, France (Recruiting)
- Centre Hospitalier Saint Joseph Saint Luc — Lyon, France (Recruiting)
- Hospices Civils de Lyon — Lyon, France (Recruiting)
- Assistance Publique - Hôpitaux de Marseille (AP-HM) — Marseille, France (Recruiting)
- CHU de Montpellier — Montpellier, France (Recruiting)
- CHU de Nantes — Nantes, France (Recruiting)
- CHU de Nimes — Nîmes, 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)
Study contacts
- Study coordinator: Lise Laclautre, PharmD
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: 04 73 754 963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.