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The Role of Host-microbiota Interplay in Hidradenitis Suppurativa Pathogenesis (VERIMMUNE)

Primary Purpose

Hidradenitis Suppurativa (HS)

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Skin Swab & Skin Biopsies & Blood Sample
Sponsored by
Association pour la Recherche Clinique et Immunologique
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hidradenitis Suppurativa (HS)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Subject able to read, understand and give documented informed consent Subject willing and able to comply with the protocol requirements for the duration of the study Subject with health insurance coverage according to local regulations For woman with childbearing potential, negative pregnancy test at the inclusion visit Specific criteria for HS patients Subject diagnosed with HS for at least 6 months Subject diagnosed with moderate-to-severe HS defined by HS PGA≥3 Subject presenting an HS with inflammatory phenotype defined by the presence of folliculitis, nodules and/or abcesses Subject suffering from at least 4 flares/year and presenting 5 active inflammatory lesions (nodules and/or abcesses) Exclusion Criteria: Pregnancy or breast-feeding women Subject treated by allergen immunotherapy within 4 weeks before inclusion Subject treated by Non-Steroidal Anti-Inflammatory Drugs (NSAID), antibiotics or proton-pump inhibitors within 4 weeks before inclusion Subject treated by live (attenuated) vaccine within 4 weeks before inclusion Subject treated by anti-viral treatment within 4 weeks before inclusion Subject treated by anti-diarrhea treatment including, but not limited to Loperamide Subject treated by immunosuppressive/immunomodulatory substances including oral corticosteroid or biological agents within 4 weeks before inclusion Subject presenting spondylo-arthritis or Inflammatory Bowel Disease (IBD) Subject with a Body Mass Index (BMI)<18.5 or BMI>35 Subject consuming probiotics or using a specific diet (e.g. gluten free, vegetarian, vegan, intermittent fasting) Subject with any additional condition that, in the opinion of the investigator, may interfere with the assessment or put the subject at risk Linguistic or mentally incapacity to sign the consent form Subject protect by the law (adult under guardianship, or hospitalized in a public or private institution for a reason other than study, or incarcerated) Subject in an exclusion period from a previous study or who is participating in another clinical trial using a drug Specific criteria for HS patients Subject currently experiencing or having a history of other concomitant skin conditions that would interfere with evaluation of HS History of allergic reaction to local anesthetic product History of wound healing disorders (e.g. hypertrophic scars, keloids) History of extensive armpit surgery Subject with known active infection to Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) Subject treated for their HS by systemic therapy, investigational or commercial, approved or off label) Subject treated for their HS by immunosuppressants or intralesional corticosteroids within 4 weeks before the inclusion Subject treated for their HS by topical antibiotics within 4 weeks before the inclusion Subject previously treated with monoclonal antibodies

Sites / Locations

  • Department of Dermatology-Hôpital Edouard Herriot

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hidradenitis Suppurativa (HS) Patients

Healthy Subjects

Arm Description

Skin swab sampling for bacteriological analysis Four skin biopsies: a 6-mm and a 4-mm section skin biopsies on a lesional area (inflammatory nodules) a 6-mm and a 4-mm section skin biopsies on a non lesional area - blood sample (16 mL)

blood sample (16 mL)

Outcomes

Primary Outcome Measures

Number of the different leucocytes subsets
Number of the different leucocytes subsets (unconventional and conventional lymphocytes) in the lesional skin versus non lesional skin Number of the different leucocytes subsets (unconventional and conventional lymphocytes) in the blood of HS patients versus healthy volunteers
Frequency of the different leucocytes subsets
Frequency of the different leucocytes subsets (unconventional and conventional lymphocytes) in the lesional skin versus non lesional skin Frequency of the different leucocytes subsets (unconventional and conventional lymphocytes) in the blood of HS patients versus healthy volunteers
Functional phenotype of the different leucocytes subsets
Functional phenotype of the different leucocytes subsets (unconventional and conventional lymphocytes) in the lesional skin versus non lesional skin Functional phenotype of the different leucocytes subsets (unconventional and conventional lymphocytes) in the blood of HS patients versus healthy volunteers

Secondary Outcome Measures

Quantitative RNA
Quantitative RNA expression of selected cytokines' genes in the lesional skin versus non lesional skin
TCR Sequencing
TCR sequencing in the lesional skin versus non-lesional skin TCR sequencing in the blood of HS patients versus healthy volunteers Correlation between lesional skin and blood clones in the same patient will be searched
Bacterial diversity
Bacterial diversity of microbes from skin flora in lesional skin versus non lesional skin
Bacterial abundance
Bacterial abundance of microbes from skin flora in lesional skin versus non lesional skin
Bacterial diversity
Bacterial diversity of microbes from gut flora in HS patients versus healthy volunteers
Bacterial abundance
Bacterial abundance of microbes from gut flora in HS patients versus healthy volunteers
Presence of bacterial DNA translocation
Presence of bacterial DNA translocation in the blood of HS patients
Description of bacterial DNA translocation
Genus, phyla, species, specific bacteria abundance and overall diversity in the blood of HS patients

Full Information

First Posted
January 30, 2023
Last Updated
February 9, 2023
Sponsor
Association pour la Recherche Clinique et Immunologique
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1. Study Identification

Unique Protocol Identification Number
NCT05735925
Brief Title
The Role of Host-microbiota Interplay in Hidradenitis Suppurativa Pathogenesis
Acronym
VERIMMUNE
Official Title
The Role of Host-microbiota Interplay in Hidradenitis Suppurativa Pathogenesis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association pour la Recherche Clinique et Immunologique

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
Hidradenitis Suppurativa (HS) is a chronic disabling inflammatory skin disorder associated with the development of painful and purulent lesions of the folds (armpits, inguinal folds, sub-mammary glands). HS most often develops in adolescence or young adulthood and is characterized by inflammation of the pilo-sebaceous system, of progressive severity (folliculitis, nodule, abscess, fistula). The pathogenesis of HS is still poorly understood: the fact that patients respond to combinations of antibiotics and/or immunosuppressive treatments suggests that the disease could be due to a dysregulated immune response against microbial skin flora. Unconventional lymphocytes (UL), classically considered being at the interface of innate and adaptive immunity, play an important role in immune protection against microbial flora. But UL dysfunction has also been reported in many autoimmune diseases involving various tissues (joints, digestive tract, skin). The uncontrolled and chronic activation of these UL by skin microbiota could therefore play a role in the pathogenesis of HS.
Detailed Description
The aim of this exploratory study is to analyze the interplay between microbiota and the innate and adaptative immune response in the pathogenesis of HS. To better understand this host-microbiota interplay, we will assess the number, frequency and functional phenotypes of the different lymphocyte subsets in HS patients, with a special focus regarding the UL. In the same time, we will assess the diversity and nature of skin microbiota of the same patients. Finally, we will explore the relation between the immune response and the skin microbiota in HS, using correlation analysis (Spearman coefficient). In this study, HS patients will be their own control for leucocyte phenotyping, cytokine analysis and T Cells Receptor (TCR) sequencing (skin biopsies) and for skin microbiota analysis. Paired (age/sex) healthy volunteers will be controls for gut microbiota analysis and for immunophenotyping of circulating leukocytes (Peripheral Blood Mononuclear Cells (PBMC) analysis).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa (HS)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hidradenitis Suppurativa (HS) Patients
Arm Type
Experimental
Arm Description
Skin swab sampling for bacteriological analysis Four skin biopsies: a 6-mm and a 4-mm section skin biopsies on a lesional area (inflammatory nodules) a 6-mm and a 4-mm section skin biopsies on a non lesional area - blood sample (16 mL)
Arm Title
Healthy Subjects
Arm Type
No Intervention
Arm Description
blood sample (16 mL)
Intervention Type
Diagnostic Test
Intervention Name(s)
Skin Swab & Skin Biopsies & Blood Sample
Intervention Description
These intervention will be necessary to phenotype the immune cells that are present in the skin and blood of HS patients
Primary Outcome Measure Information:
Title
Number of the different leucocytes subsets
Description
Number of the different leucocytes subsets (unconventional and conventional lymphocytes) in the lesional skin versus non lesional skin Number of the different leucocytes subsets (unconventional and conventional lymphocytes) in the blood of HS patients versus healthy volunteers
Time Frame
Day 0
Title
Frequency of the different leucocytes subsets
Description
Frequency of the different leucocytes subsets (unconventional and conventional lymphocytes) in the lesional skin versus non lesional skin Frequency of the different leucocytes subsets (unconventional and conventional lymphocytes) in the blood of HS patients versus healthy volunteers
Time Frame
Day 0
Title
Functional phenotype of the different leucocytes subsets
Description
Functional phenotype of the different leucocytes subsets (unconventional and conventional lymphocytes) in the lesional skin versus non lesional skin Functional phenotype of the different leucocytes subsets (unconventional and conventional lymphocytes) in the blood of HS patients versus healthy volunteers
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Quantitative RNA
Description
Quantitative RNA expression of selected cytokines' genes in the lesional skin versus non lesional skin
Time Frame
Day 0
Title
TCR Sequencing
Description
TCR sequencing in the lesional skin versus non-lesional skin TCR sequencing in the blood of HS patients versus healthy volunteers Correlation between lesional skin and blood clones in the same patient will be searched
Time Frame
Day 0
Title
Bacterial diversity
Description
Bacterial diversity of microbes from skin flora in lesional skin versus non lesional skin
Time Frame
Day 0
Title
Bacterial abundance
Description
Bacterial abundance of microbes from skin flora in lesional skin versus non lesional skin
Time Frame
Day 0
Title
Bacterial diversity
Description
Bacterial diversity of microbes from gut flora in HS patients versus healthy volunteers
Time Frame
Day 14
Title
Bacterial abundance
Description
Bacterial abundance of microbes from gut flora in HS patients versus healthy volunteers
Time Frame
Day 14
Title
Presence of bacterial DNA translocation
Description
Presence of bacterial DNA translocation in the blood of HS patients
Time Frame
Day 0
Title
Description of bacterial DNA translocation
Description
Genus, phyla, species, specific bacteria abundance and overall diversity in the blood of HS patients
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subject able to read, understand and give documented informed consent Subject willing and able to comply with the protocol requirements for the duration of the study Subject with health insurance coverage according to local regulations For woman with childbearing potential, negative pregnancy test at the inclusion visit Specific criteria for HS patients Subject diagnosed with HS for at least 6 months Subject diagnosed with moderate-to-severe HS defined by HS PGA≥3 Subject presenting an HS with inflammatory phenotype defined by the presence of folliculitis, nodules and/or abcesses Subject suffering from at least 4 flares/year and presenting 5 active inflammatory lesions (nodules and/or abcesses) Exclusion Criteria: Pregnancy or breast-feeding women Subject treated by allergen immunotherapy within 4 weeks before inclusion Subject treated by Non-Steroidal Anti-Inflammatory Drugs (NSAID), antibiotics or proton-pump inhibitors within 4 weeks before inclusion Subject treated by live (attenuated) vaccine within 4 weeks before inclusion Subject treated by anti-viral treatment within 4 weeks before inclusion Subject treated by anti-diarrhea treatment including, but not limited to Loperamide Subject treated by immunosuppressive/immunomodulatory substances including oral corticosteroid or biological agents within 4 weeks before inclusion Subject presenting spondylo-arthritis or Inflammatory Bowel Disease (IBD) Subject with a Body Mass Index (BMI)<18.5 or BMI>35 Subject consuming probiotics or using a specific diet (e.g. gluten free, vegetarian, vegan, intermittent fasting) Subject with any additional condition that, in the opinion of the investigator, may interfere with the assessment or put the subject at risk Linguistic or mentally incapacity to sign the consent form Subject protect by the law (adult under guardianship, or hospitalized in a public or private institution for a reason other than study, or incarcerated) Subject in an exclusion period from a previous study or who is participating in another clinical trial using a drug Specific criteria for HS patients Subject currently experiencing or having a history of other concomitant skin conditions that would interfere with evaluation of HS History of allergic reaction to local anesthetic product History of wound healing disorders (e.g. hypertrophic scars, keloids) History of extensive armpit surgery Subject with known active infection to Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) Subject treated for their HS by systemic therapy, investigational or commercial, approved or off label) Subject treated for their HS by immunosuppressants or intralesional corticosteroids within 4 weeks before the inclusion Subject treated for their HS by topical antibiotics within 4 weeks before the inclusion Subject previously treated with monoclonal antibodies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie GILIBERT, PhD
Phone
+33 6 65 37 50 08
Email
sophie.gilibert@lyonrechercheclinique.com
Facility Information:
Facility Name
Department of Dermatology-Hôpital Edouard Herriot
City
Lyon
State/Province
Rhône
ZIP/Postal Code
69003
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Axel VILLANI, M.D Ph.D
Phone
04 72 11 72 11
Email
axel.villani@chu-lyon.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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The Role of Host-microbiota Interplay in Hidradenitis Suppurativa Pathogenesis

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