Prospective Interventional Study Exploring the Microbiota Recolonization in SR-GvHD Patients Receiving MaaT013
NCT05017688 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2023-10-11
Summary
The objective of the ORION study is to explore the changes of gut microbiota composition following MaaT013 administration and its impact on the immune system in GVHD patients.
Conditions
- Intestinal GVHD
- Steroid Refractory GVHD
Interventions
- PROCEDURE
-
Blood and stool sample collection
Collection of blood samples (55 mL) Collection of fecal samples (10g)
Sponsors & Collaborators
-
MaaT Pharma
lead INDUSTRY
Principal Investigators
-
Sarah Guenounou, MD · IUCT ONCOPOLE
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-10-06
- Primary Completion
- 2024-06-30
- Completion
- 2024-12-31
Countries
- France
Study Locations
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