Aseptic Abscess SyndromeABSCESSBIOTNCT05537909
Role of Gut Microbiota in the Pathophysiology of Aseptic Abscesses
A study testing Biological sample collection in people with Aseptic Abscess Syndrome, run by University Hospital, Clermont-Ferrand at 15 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aseptic Abscess Syndrome
- What is being tested?
- Biological sample collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 15 sitesFrance
- Study dates
- 7 Sep 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnant women. Incapable patients Patients deprived of liberty Antibiotic therapy administered within 6 weeks prior to inclusion.
Trial locations and contacts
15 sites in 1 country.
Trefond Ludovic, MD contact
15 sites in 1 country
France15 sites, 15 recruiting
- Recruiting
CHU de Bordeaux
Bordeaux, 33000
Lise Laclautre, PharmD, 04 73 754 963, promo_interne_drci@chu-clermontferrand.fr
Jean-Francois VIALLARD, MD
- Recruiting
Centre Hospitalier Intercommunal Nord-Ardennes
Charleville-Mézières, 08011
Lise Laclautre, PharmD, 04 73 754 963 ext. 33, promo_interne_drci@chu-clermontferrand.fr
Jean-Michel GALEMPOIX, MD
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, Pharm D, 04 73 754 963 ext. 33, promo_interne_drci@chu-clermontferrand.fr
Marc ANDRE, MD
- Recruiting
CHU Henri Mondor - Assistance Publique -Hôpitaux de Paris (AP-HP)
Créteil
Lise Laclautre, PharmD, 04 73 754 963 ext. 33, promo_interne_drci@chu-clermontferrand.fr
Olivier CHOSIDOW, MD
- Recruiting
Centre Hospitalier de Dax
Dax, 40107
Lise Laclautre, PharmD, 04 73 754 963 ext. 33, promo_interne_drci@chu-clermontferrand.fr
Francois LIFERMANN, MD
- Recruiting
Centre Hospitalier Saint Joseph Saint Luc
Lyon, 69000
Lise Laclautre, PharmD, 04 73 754 963 ext. 33, promo_interne_drci@chu-clermontferrand.fr
- Recruiting
Hospices Civils de Lyon
Lyon, 69000
Lise Laclautre, PharmD, 04 73 754 963 ext. 33, promo_interne_drci@chu-clermontferrand.fr
Hélène DESMURS-CLAVEL, MD
- Recruiting
Assistance Publique - Hôpitaux de Marseille (AP-HM)
Marseille, 13000
Lise Laclautre, PharmD, 04 73 754 963 ext. 33, promo_interne_drci@chu-clermontferrand.fr
Laure SWIADER, MD
- Recruiting
CHU de Montpellier
Montpellier, 34000
Lise Laclautre, PharmD, 04 73 754 963, promo_interne_drci@chu-clermontferrand.fr
Romain ALTWEGG, MD
- Recruiting
CHU de Nantes
Nantes, 44093
Lise Laclautre, PharmD, 04 73 754 730 ext. 33, promo_interne_drci@chu-clermontferrand.fr
Jérome CONNAULT, MD
- Recruiting
CHU de Nimes
Nîmes, 30029
Lise Laclautre, PharmD, 04 73 754 963 ext. 33, promo_interne_drci@chu-clermontferrand.fr
Jean-François BOURGAUX, MD
- Recruiting
Hôpital Cochin - Assistance Publique -Hôpitaux de Paris (AP-HP)
Paris
Lise Laclautre, PharmD, 04 73 754 730, promo-interne-drci@chu-clermontferrand.fr
Nathalie COSTEDOAT-CHALUMEAU, MD
- Recruiting
Hôpital La Pitié-Salpétrière - Assistance Publique -Hôpitaux de Paris (AP-HP)
Paris
Lise Laclautre, PharmD, 04 73 754 730, promo_interne_drci@chu-clermontferrand.fr
Jean-Charles PIETTE, MD
- Recruiting
Hôpital Louis Mourier - Assistance Publique -Hôpitaux de Paris (AP-HP)
Paris
Lise Laclautre, PharmD, 04 73 754 963 ext. 33, promo_interne_drci@chu-clermontferrand.fr
Elisabeth ASLANGUL, MD
- Recruiting
Hôpital Saint Louis Lariboisière - Assistance Publique -Hôpitaux de Paris (AP-HP)
Paris
Lise Laclautre, PharmD, 04 73 754 730 ext. 33, promo_interne_drci@chu-clermontferrand.fr
Clémence LEPELLETIER, MD
About this study
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.
Read the 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.
- Conditions
- Aseptic Abscess Syndrome
- Being tested
- Biological sample collection
- Keywords
- Aseptic abscess syndrome, Comparative Study, Pathophysiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological sample collectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | adult patients with aseptic abscess syndrome Receives: Other: Biological sample collection |
| control | Experimental | control An adult person living in the same environment as the case. Receives: Other: Biological sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: day 1
Secondary outcomes (3)
Th17/Treg Lymphocytes phenotyping
Th17/Treg Lymphocytes phenotyping of patients with aseptic abscesses compared to matched healthy controls.
Measured: 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.
Measured: 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.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start7 Sep 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aseptic Abscess SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537909
- Sponsor's protocol ID
- RBHP ANDRE (ABSCESSBIOT)
- Other IDs
- 2017-A03499-44
- Acronym
- ABSCESSBIOT
- Status last verified
- Feb 2024
- First submitted
- 17 Jun 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37541750
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Gut Microbiota in the Pathophysiology of Aseptic Abscesses
- ClinicalTrials.gov ID
- NCT05537909
- Acronym / sponsor ID
- ABSCESSBIOT / RBHP ANDRE (ABSCESSBIOT)
- Conditions
- Aseptic Abscess Syndrome
- Keywords
- Aseptic abscess syndrome, Comparative Study, Pathophysiology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Other: Biological sample collectionadult patients with aseptic abscess syndrome |
| control | Experimental | Other: Biological sample collectioncontrol An adult person living in the same environment as the case. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (1 listed)
- Pregnant women. Incapable patients Patients deprived of liberty Antibiotic therapy administered within 6 weeks prior to inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological sample collectionAll 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. | Other | Patients, control |
Primary outcome
Gut microbiota profiling (diversity) of patients with aseptic abscess syndrome and matched healthy controls
Time frame: 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.
Gut microbiota profiling (composition) of patients with aseptic abscess syndrome and matched healthy controls
Time frame: 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.
3 secondary outcomes
Th17/Treg Lymphocytes phenotyping
Time frame: day 1
Salivary microbiota profiling (composition) of patients with aseptic abscess syndrome and matched healthy controls
Time frame: day 1
Salivary microbiota profiling (diversity) of patients with aseptic abscess syndrome and matched healthy controls
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 37541750Trefond 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trefond Ludovic, MD contact
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological sample collection in people with Aseptic Abscess Syndrome, run by University Hospital, Clermont-Ferrand at 15 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre, PharmD (04 73 754 963 ext. 33, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiota profiling (diversity) of patients with aseptic abscess syndrome and matched healthy controls (time frame: day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05537909, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 8 Nov 2026.