Dysbiosis and Immune Reconstitution After Allo-HSCT (PARI-DYS)
Primary Purpose
Hematopoietic Stem Cell Transplantation
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood samples
fecal samples
Anxiety test
Stress test
Sponsored by
About this trial
This is an interventional basic science trial for Hematopoietic Stem Cell Transplantation focused on measuring HSCT, intestinal dysbiosis, immune reconstitution
Eligibility Criteria
Inclusion Criteria:
- Patients > 18 years affiliated to a social security system
- Patients followed at the hospital of Nancy for a allogeneic hematopoietic cell transplantation (HLA matched donor)
- Graft of peripheral blood stem cell
- GVHD prophylaxis by ciclosporin and antilymphocyte serum +/- mycophenolate mofetil or methotrexate.
Exclusion Criteria:
- HIV+ patients
- Patients with active HBV or HCV
Sites / Locations
- RUBIO Marie-ThérèseRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient
Arm Description
For all patients included in the study, the following interventions will be performed : several blood samples (quantity collected requiring classification of this study as interventional according to French law) several fecal samples anxiety tests stress tests
Outcomes
Primary Outcome Measures
quality of iNKT reconstitution after HSCT (good/poor)
Secondary Outcome Measures
gut microbiota composition
relative abundance of intestinal bacterial taxa
immune reconstitution after HSCT (other immune cells)
quantification of Tregs, MDSC, MAIT, T lymphocytes
GVH disease
yes/not
use of antibiotics
yes/not (molecules, delay, posology)
level of stress
test of Cohen
level of anxiety
test of Spielberger
quality of iNKT reconstitution after HSCT (good/poor)
Full Information
NCT ID
NCT03616015
First Posted
July 19, 2018
Last Updated
January 30, 2019
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT03616015
Brief Title
Dysbiosis and Immune Reconstitution After Allo-HSCT
Acronym
PARI-DYS
Official Title
Intestinal Dysbiosis and Immune Reconstitution After Allogeneic Hematopoietic Cell Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 4, 2018 (Actual)
Primary Completion Date
January 31, 2021 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematopoietic Stem Cell Transplantation
Keywords
HSCT, intestinal dysbiosis, immune reconstitution
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient
Arm Type
Experimental
Arm Description
For all patients included in the study, the following interventions will be performed :
several blood samples (quantity collected requiring classification of this study as interventional according to French law)
several fecal samples
anxiety tests
stress tests
Intervention Type
Biological
Intervention Name(s)
blood samples
Intervention Description
20 to 30 ml of blood sample (D0, D15, D30, D60, D90, D180, Y1, Y2)
Intervention Type
Biological
Intervention Name(s)
fecal samples
Intervention Description
1 g of feces (D-8, D0, D15, D30, D90)
Intervention Type
Behavioral
Intervention Name(s)
Anxiety test
Intervention Description
Test of Spielberger
Intervention Type
Behavioral
Intervention Name(s)
Stress test
Intervention Description
Test of Cohen
Primary Outcome Measure Information:
Title
quality of iNKT reconstitution after HSCT (good/poor)
Time Frame
Day 90,
Secondary Outcome Measure Information:
Title
gut microbiota composition
Description
relative abundance of intestinal bacterial taxa
Time Frame
Day 0, Day 15, Day 30, Day 90
Title
immune reconstitution after HSCT (other immune cells)
Description
quantification of Tregs, MDSC, MAIT, T lymphocytes
Time Frame
Day 15, Day 30, Day 60, Day 90, Day 180, Year 1, Year 2
Title
GVH disease
Description
yes/not
Time Frame
Day 30, Day 60, Day 90
Title
use of antibiotics
Description
yes/not (molecules, delay, posology)
Time Frame
Day 0, Day 15, Day 30, Day 60, Day 90
Title
level of stress
Description
test of Cohen
Time Frame
Day -8, Day 15, Day 30, Day 90
Title
level of anxiety
Description
test of Spielberger
Time Frame
Day -8, Day 15, Day 30, Day 90
Title
quality of iNKT reconstitution after HSCT (good/poor)
Time Frame
Day 15, Day 30, Day 60, Day 180, Year 1, Year2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients > 18 years affiliated to a social security system
Patients followed at the hospital of Nancy for a allogeneic hematopoietic cell transplantation (HLA matched donor)
Graft of peripheral blood stem cell
GVHD prophylaxis by ciclosporin and antilymphocyte serum +/- mycophenolate mofetil or methotrexate.
Exclusion Criteria:
HIV+ patients
Patients with active HBV or HCV
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Corentine ALAUZET, Dr
Phone
0383153938
Ext
+33
Email
c.alauzet@chru-nancy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Thérèse RUBIO, Pr
Phone
0383153257
Ext
+33
Email
m.rubio@chru-nancy.fr
Facility Information:
Facility Name
RUBIO Marie-Thérèse
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Thérèse RUBIO, PU-PH
Phone
383153282
12. IPD Sharing Statement
Learn more about this trial
Dysbiosis and Immune Reconstitution After Allo-HSCT
We'll reach out to this number within 24 hrs