Trials / Unknown
UnknownNCT03616015
Dysbiosis and Immune Reconstitution After Allo-HSCT
Intestinal Dysbiosis and Immune Reconstitution After Allogeneic Hematopoietic Cell Transplantation
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Central Hospital, Nancy, France · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2018-12-04
- Primary completion
- 2021-01-31
- Completion
- 2022-09-01
- First posted
- 2018-08-06
- Last updated
- 2019-02-01
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03616015. Inclusion in this directory is not an endorsement.