Dysbiosis and Immune Reconstitution After Allo-HSCT

Overview

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).

Full Title of Study: “Intestinal Dysbiosis and Immune Reconstitution After Allogeneic Hematopoietic Cell Transplantation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 31, 2021

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.

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

Arms, Groups and Cohorts

  • Experimental: Patient
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • quality of iNKT reconstitution after HSCT (good/poor)
    • Time Frame: Day 90,

Secondary Measures

  • gut microbiota composition
    • Time Frame: Day 0, Day 15, Day 30, Day 90
    • relative abundance of intestinal bacterial taxa
  • immune reconstitution after HSCT (other immune cells)
    • Time Frame: Day 15, Day 30, Day 60, Day 90, Day 180, Year 1, Year 2
    • quantification of Tregs, MDSC, MAIT, T lymphocytes
  • GVH disease
    • Time Frame: Day 30, Day 60, Day 90
    • yes/not
  • use of antibiotics
    • Time Frame: Day 0, Day 15, Day 30, Day 60, Day 90
    • yes/not (molecules, delay, posology)
  • level of stress
    • Time Frame: Day -8, Day 15, Day 30, Day 90
    • test of Cohen
  • level of anxiety
    • Time Frame: Day -8, Day 15, Day 30, Day 90
    • test of Spielberger
  • quality of iNKT reconstitution after HSCT (good/poor)
    • Time Frame: Day 15, Day 30, Day 60, Day 180, Year 1, Year2

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Central Hospital, Nancy, France
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Corentine ALAUZET, Dr, 0383153938, c.alauzet@chru-nancy.fr

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