NCT03616015

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

December 4, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

2.2 years

First QC Date

July 19, 2018

Last Update Submit

January 30, 2019

Conditions

Hematopoietic Stem Cell Transplantation

Keywords

HSCTintestinal dysbiosisimmune reconstitution

Outcome Measures

Primary Outcomes (1)

  • quality of iNKT reconstitution after HSCT (good/poor)

    Day 90,

Secondary Outcomes (7)

  • gut microbiota composition

    Day 0, Day 15, Day 30, Day 90

  • immune reconstitution after HSCT (other immune cells)

    Day 15, Day 30, Day 60, Day 90, Day 180, Year 1, Year 2

  • GVH disease

    Day 30, Day 60, Day 90

  • use of antibiotics

    Day 0, Day 15, Day 30, Day 60, Day 90

  • level of stress

    Day -8, Day 15, Day 30, Day 90

  • +2 more secondary outcomes

Study Arms (1)

Patient

EXPERIMENTAL

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

Biological: blood samplesBiological: fecal samplesBehavioral: Anxiety testBehavioral: Stress test

Interventions

blood samplesBIOLOGICAL

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

Patient
fecal samplesBIOLOGICAL

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

Patient
Anxiety testBEHAVIORAL

Test of Spielberger

Patient
Stress testBEHAVIORAL

Test of Cohen

Patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • HIV+ patients
  • Patients with active HBV or HCV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RUBIO Marie-Thérèse

Vandœuvre-lès-Nancy, 54511, France

RECRUITING

MeSH Terms

Interventions

Blood Specimen CollectionTest Anxiety ScaleExercise Test

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesPersonality InventoryPersonality TestsPsychological TestsBehavioral Disciplines and ActivitiesHeart Function TestsDiagnostic Techniques, CardiovascularRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometry

Central Study Contacts

Corentine ALAUZET, Dr

CONTACT

0383153938c.alauzet@chru-nancy.fr

Marie-Thérèse RUBIO, Pr

CONTACT

0383153257m.rubio@chru-nancy.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2018

First Posted

August 6, 2018

Study Start

December 4, 2018

Primary Completion

January 31, 2021

Study Completion

September 1, 2022

Last Updated

February 1, 2019

Record last verified: 2019-01

Locations

FR(1)