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

Primary Purpose

Aseptic Abscess Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biological sample collection
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Aseptic Abscess Syndrome focused on measuring Aseptic abscess syndrome, Comparative Study, Pathophysiology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • CHU de BordeauxRecruiting
  • Centre Hospitalier Intercommunal Nord-ArdennesRecruiting
  • CHU de Clermont-FerrandRecruiting
  • CHU Henri Mondor - Assistance Publique -Hôpitaux de Paris (AP-HP)Recruiting
  • Centre Hospitalier de DaxRecruiting
  • Centre Hospitalier Saint Joseph Saint LucRecruiting
  • Hospices Civils de LyonRecruiting
  • Assistance Publique - Hôpitaux de Marseille (AP-HM)Recruiting
  • CHU de MontpellierRecruiting
  • CHU de NantesRecruiting
  • CHU de NimesRecruiting
  • Hôpital Cochin - Assistance Publique -Hôpitaux de Paris (AP-HP)Recruiting
  • Hôpital La Pitié-Salpétrière - Assistance Publique -Hôpitaux de Paris (AP-HP)Recruiting
  • Hôpital Louis Mourier - Assistance Publique -Hôpitaux de Paris (AP-HP)Recruiting
  • Hôpital Saint Louis Lariboisière - Assistance Publique -Hôpitaux de Paris (AP-HP)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patients

control

Arm Description

adult patients with aseptic abscess syndrome

control An adult person living in the same environment as the case.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Th17/Treg Lymphocytes phenotyping
Th17/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 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.
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.

Full Information

First Posted
June 17, 2022
Last Updated
September 15, 2022
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT05537909
Brief Title
Role of Gut Microbiota in the Pathophysiology of Aseptic Abscesses
Acronym
ABSCESSBIOT
Official Title
Role of Gut Microbiota in the Pathophysiology of Aseptic Abscesses
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2021 (Actual)
Primary Completion Date
September 7, 2021 (Actual)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aseptic Abscess Syndrome
Keywords
Aseptic abscess syndrome, Comparative Study, Pathophysiology

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Experimental
Arm Description
adult patients with aseptic abscess syndrome
Arm Title
control
Arm Type
Experimental
Arm Description
control An adult person living in the same environment as the case.
Intervention Type
Other
Intervention Name(s)
Biological sample collection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gut microbiota profiling (diversity) of patients with aseptic abscess syndrome and matched healthy controls
Description
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.
Time Frame
day 1
Title
Gut microbiota profiling (composition) of patients with aseptic abscess syndrome and matched healthy controls
Description
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.
Time Frame
day 1
Secondary Outcome Measure Information:
Title
Th17/Treg Lymphocytes phenotyping
Description
Th17/Treg Lymphocytes phenotyping of patients with aseptic abscesses compared to matched healthy controls.
Time Frame
day 1
Title
Salivary microbiota profiling (composition) of patients with aseptic abscess syndrome and matched healthy controls
Description
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.
Time Frame
day 1
Title
Salivary microbiota profiling (diversity) of patients with aseptic abscess syndrome and matched healthy controls
Description
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.
Time Frame
day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise Laclautre, PharmD
Phone
04 73 754 963
Ext
33
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Trefond Ludovic, MD
Email
promo_interne_drci@chu-clermontferrand.fr
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre, PharmD
Phone
04 73 754 963
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Jean-Francois VIALLARD, MD
First Name & Middle Initial & Last Name & Degree
Fabrice BONNET, MD
Facility Name
Centre Hospitalier Intercommunal Nord-Ardennes
City
Charleville-Mézières
ZIP/Postal Code
08011
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre, PharmD
Phone
04 73 754 963
Ext
33
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Jean-Michel GALEMPOIX, MD
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre, Pharm D
Phone
04 73 754 963
Ext
33
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Marc ANDRE, MD
First Name & Middle Initial & Last Name & Degree
Ludovic TREFOND, MD
First Name & Middle Initial & Last Name & Degree
Olivier AUMAITRE, MD
Facility Name
CHU Henri Mondor - Assistance Publique -Hôpitaux de Paris (AP-HP)
City
Créteil
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre, PharmD
Phone
04 73 754 963
Ext
33
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Olivier CHOSIDOW, MD
Facility Name
Centre Hospitalier de Dax
City
Dax
ZIP/Postal Code
40107
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre, PharmD
Phone
04 73 754 963
Ext
33
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Francois LIFERMANN, MD
Facility Name
Centre Hospitalier Saint Joseph Saint Luc
City
Lyon
ZIP/Postal Code
69000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre, PharmD
Phone
04 73 754 963
Ext
33
Email
promo_interne_drci@chu-clermontferrand.fr
Facility Name
Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre, PharmD
Phone
04 73 754 963
Ext
33
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Hélène DESMURS-CLAVEL, MD
Facility Name
Assistance Publique - Hôpitaux de Marseille (AP-HM)
City
Marseille
ZIP/Postal Code
13000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre, PharmD
Phone
04 73 754 963
Ext
33
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Laure SWIADER, MD
Facility Name
CHU de Montpellier
City
Montpellier
ZIP/Postal Code
34000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre, PharmD
Phone
04 73 754 963
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Romain ALTWEGG, MD
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre, PharmD
Phone
04 73 754 730
Ext
33
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Jérome CONNAULT, MD
Facility Name
CHU de Nimes
City
Nîmes
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre, PharmD
Phone
04 73 754 963
Ext
33
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Jean-François BOURGAUX, MD
Facility Name
Hôpital Cochin - Assistance Publique -Hôpitaux de Paris (AP-HP)
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre, PharmD
Phone
04 73 754 730
Email
promo-interne-drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Nathalie COSTEDOAT-CHALUMEAU, MD
Facility Name
Hôpital La Pitié-Salpétrière - Assistance Publique -Hôpitaux de Paris (AP-HP)
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre, PharmD
Phone
04 73 754 730
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Jean-Charles PIETTE, MD
Facility Name
Hôpital Louis Mourier - Assistance Publique -Hôpitaux de Paris (AP-HP)
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre, PharmD
Phone
04 73 754 963
Ext
33
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Elisabeth ASLANGUL, MD
Facility Name
Hôpital Saint Louis Lariboisière - Assistance Publique -Hôpitaux de Paris (AP-HP)
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre, PharmD
Phone
04 73 754 730
Ext
33
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Clémence LEPELLETIER, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Role of Gut Microbiota in the Pathophysiology of Aseptic Abscesses

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