Dysbiosis and Immune Reconstitution After Allo-HSCT

Hematopoietic Stem Cell Transplantation Clinical Trial

— PARI-DYS  

Official title:

Intestinal Dysbiosis and Immune Reconstitution After Allogeneic Hematopoietic Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03616015
• Other study ID #: 2018-A00676-49
• Status: Recruiting
• Phase: N/A
• Start date: December 4, 2018
• Est. completion date: September 1, 2022

Study information

• Verified date: January 2019
• Source: Central Hospital, Nancy, France
• Contact: Corentine ALAUZET, Dr
• Phone: 0383153938
• Email: c.alauzet[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 1, 2022
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dysbiosis
• Hematopoietic Stem Cell Transplantation

Intervention

Biological:
• blood samples
20 to 30 ml of blood sample (D0, D15, D30, D60, D90, D180, Y1, Y2)
• fecal samples
1 g of feces (D-8, D0, D15, D30, D90)

Behavioral:
• Anxiety test
Test of Spielberger
• Stress test
Test of Cohen

Locations

Country	Name	City	State
France	RUBIO Marie-Thérèse	Vandoeuvre Les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

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