Role of Brodalumab in the Modulation of Gut Microbiome in Psoriatic Patients
NCT04680624 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2020-12-23
Summary
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.
Conditions
Interventions
- PROCEDURE
-
Fecal sample collection
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.
Sponsors & Collaborators
-
Association pour la Recherche Clinique et Immunologique
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-01-31
- Primary Completion
- 2022-01-31
- Completion
- 2022-01-31
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