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).
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the major curative therapeutic approach for hematologic neoplasms. After HSCT, patients have a compromised GI mucosal barrier and an altered microbiota, also called dysbiosis. The later could be due to conditioning or use of broad-spectrum antibiotics, and could be accentuate by stress encountered by patients during their therapy management. Recent data have shown that alterations in the intestinal flora are associated with bad outcome, particularly with graft-versus-host disease (GVHD), bacteremia, and reduced overall survival post-transplantation. How intestinal bacteria can modulate the risk of relapse after HSCT is yet unknown. The scientists hypothesize that the variation of some bacterial taxa may influence post-transplant immune reconstitution, particularly invariant Natural Killer T cells.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
80
20 to 30 ml of blood sample (D0, D15, D30, D60, D90, D180, Y1, Y2)
1 g of feces (D-8, D0, D15, D30, D90)
Test of Spielberger
RUBIO Marie-Thérèse
Vandœuvre-lès-Nancy, France
RECRUITINGquality of iNKT reconstitution after HSCT (good/poor)
Time frame: Day 90,
gut microbiota composition
relative abundance of intestinal bacterial taxa
Time frame: Day 0, Day 15, Day 30, Day 90
immune reconstitution after HSCT (other immune cells)
quantification of Tregs, MDSC, MAIT, T lymphocytes
Time frame: Day 15, Day 30, Day 60, Day 90, Day 180, Year 1, Year 2
GVH disease
yes/not
Time frame: Day 30, Day 60, Day 90
use of antibiotics
yes/not (molecules, delay, posology)
Time frame: Day 0, Day 15, Day 30, Day 60, Day 90
level of stress
test of Cohen
Time frame: Day -8, Day 15, Day 30, Day 90
level of anxiety
test of Spielberger
Time frame: Day -8, Day 15, Day 30, Day 90
quality of iNKT reconstitution after HSCT (good/poor)
Time frame: Day 15, Day 30, Day 60, Day 180, Year 1, Year2
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Test of Cohen