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BOMOGUMIP is an interventional research with minimal risk and constraints (cat.2), exploratory, intra-individual, prospective, multi-site study. The main objective of this intra individual prospective study is to determine the evolution of microbial composition of fecal samples issued to 15 patients after 6 months of Brodalumab treatment.
The population will consist of 15 adult patients suffering from moderate to severe skin psoriasis and starting, after having received a methotrexate treatment during at least 4 months, a brodalumab treatment in the first line of biological treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Group | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal sample collection | Procedure | During the study, patients will be ask to collect fecal samples using sample collection kits. A total of 4 stool samples per patient will be collected. |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of microbial composition of fecal samples after 6 months of Brodalumab treatment. | Microbial features impacted by anti-interleukin-17 treatment (Brodalumab). | At 6 months (Comparison V3/V1) |
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Inclusion Criteria:
Subject over 18 years of age
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;
Woman with no childbearing potential is defined as: woman with amenorrhea for at least 12 months (without an alternative medical cause); woman who had undergone a permanent sterilization method (eg bilateral tubal occlusion which includes tubal ligation procedures, hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or otherwise be incapable of pregnancy.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sophie Gilibert | Contact | +33478861859 | sophie.gilibert@lyonrechercheclinique.com |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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