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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient | Experimental | For all patients included in the study, the following interventions will be performed :
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood samples | Biological | 20 to 30 ml of blood sample (D0, D15, D30, D60, D90, D180, Y1, Y2) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| quality of iNKT reconstitution after HSCT (good/poor) | Day 90, |
| Measure | Description | Time Frame |
|---|---|---|
| gut microbiota composition | relative abundance of intestinal bacterial taxa | Day 0, Day 15, Day 30, Day 90 |
| immune reconstitution after HSCT (other immune cells) | quantification of Tregs, MDSC, MAIT, T lymphocytes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Corentine ALAUZET, Dr | Contact | 0383153938 | +33 | c.alauzet@chru-nancy.fr |
| Marie-Thérèse RUBIO, Pr | Contact | 0383153257 | +33 | m.rubio@chru-nancy.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RUBIO Marie-Thérèse | Recruiting | Vandœuvre-lès-Nancy | 54511 | France |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D013732 | Test Anxiety Scale |
| D005080 | Exercise Test |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| fecal samples |
| Biological |
1 g of feces (D-8, D0, D15, D30, D90) |
|
| Anxiety test | Behavioral | Test of Spielberger |
|
| Stress test | Behavioral | Test of Cohen |
|
| Day 15, Day 30, Day 60, Day 90, Day 180, Year 1, Year 2 |
| GVH disease | yes/not | Day 30, Day 60, Day 90 |
| use of antibiotics | yes/not (molecules, delay, posology) | Day 0, Day 15, Day 30, Day 60, Day 90 |
| level of stress | test of Cohen | Day -8, Day 15, Day 30, Day 90 |
| level of anxiety | test of Spielberger | Day -8, Day 15, Day 30, Day 90 |
| quality of iNKT reconstitution after HSCT (good/poor) | Day 15, Day 30, Day 60, Day 180, Year 1, Year2 |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D010555 | Personality Inventory |
| D010556 | Personality Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |