Dysbiosis and Immune Reconstitution After Allo-HSCT
NCT03616015 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2019-02-01
Summary
Preliminary (proof of concept), monocentric, interventional, prospective, non-randomized and analytic trial designed to simultaneously explore intestinal microbiota changes and early post-transplant immune reconstitution, and to correlate biological data with clinical data (antibiotics use, stress level, GVHD).
Conditions
- Hematopoietic Stem Cell Transplantation
Interventions
- BIOLOGICAL
-
blood samples
20 to 30 ml of blood sample (D0, D15, D30, D60, D90, D180, Y1, Y2)
- BIOLOGICAL
-
fecal samples
1 g of feces (D-8, D0, D15, D30, D90)
- BEHAVIORAL
-
Anxiety test
Test of Spielberger
- BEHAVIORAL
-
Stress test
Test of Cohen
Sponsors & Collaborators
-
Central Hospital, Nancy, France
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
- 2018-12-04
- Primary Completion
- 2021-01-31
- Completion
- 2022-09-01
Countries
- France
Study Locations
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