Dysbiosis and Immune Reconstitution After Allo-HSCT

NCT ID: NCT03616015

Last Updated: 2019-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-04

Study Completion Date

2022-09-01

Brief Summary

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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).

Detailed Description

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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

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Hematopoietic Stem Cell Transplantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

blood samples

Intervention Type BIOLOGICAL

20 to 30 ml of blood sample (D0, D15, D30, D60, D90, D180, Y1, Y2)

fecal samples

Intervention Type BIOLOGICAL

1 g of feces (D-8, D0, D15, D30, D90)

Anxiety test

Intervention Type BEHAVIORAL

Test of Spielberger

Stress test

Intervention Type BEHAVIORAL

Test of Cohen

Interventions

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blood samples

20 to 30 ml of blood sample (D0, D15, D30, D60, D90, D180, Y1, Y2)

Intervention Type BIOLOGICAL

fecal samples

1 g of feces (D-8, D0, D15, D30, D90)

Intervention Type BIOLOGICAL

Anxiety test

Test of Spielberger

Intervention Type BEHAVIORAL

Stress test

Test of Cohen

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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RUBIO Marie-Thérèse

Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Corentine ALAUZET, Dr

Role: CONTACT

0383153938 ext. +33

Marie-Thérèse RUBIO, Pr

Role: CONTACT

0383153257 ext. +33

Facility Contacts

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Marie-Thérèse RUBIO, PU-PH

Role: primary

383153282

Other Identifiers

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2018-A00676-49

Identifier Type: -

Identifier Source: org_study_id

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