Hematopoietic Stem Cell TransplantationPARI-DYSNCT03616015
Dysbiosis and Immune Reconstitution After Allo-HSCT
A study testing blood samples, fecal samples and Anxiety test in people with Hematopoietic Stem Cell Transplantation, run by Central Hospital, Nancy, France at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation
- What is being tested?
- blood samples, fecal samples and Anxiety test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 4 Dec 2018to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- HIV+ patients
- Patients with active HBV or HCV
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
RUBIO Marie-Thérèse
Vandœuvre-lès-Nancy, 54511
Marie-Thérèse RUBIO, PU-PH, 383153282
About this study
Official title: Intestinal Dysbiosis and Immune Reconstitution After Allogeneic Hematopoietic Cell Transplantation
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).
Read the 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
- Hematopoietic Stem Cell Transplantation
- Being tested
- blood samples, fecal samples, Anxiety test, Stress test
- Keywords
- HSCT, intestinal dysbiosis, immune reconstitution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesBiological
20 to 30 ml of blood sample (D0, D15, D30, D60, D90, D180, Y1, Y2)
fecal samplesBiological
1 g of feces (D-8, D0, D15, D30, D90)
Anxiety testBehavioural
Test of Spielberger
Stress testBehavioural
Test of Cohen
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: blood samples; Biological: fecal samples; Behavioral: Anxiety test; Behavioral: Stress test |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of iNKT reconstitution after HSCT (good/poor)
Measured: Day 90,
Secondary outcomes (7)
gut microbiota composition
relative abundance of intestinal bacterial taxa
Measured: Day 0, Day 15, Day 30, Day 90
immune reconstitution after HSCT (other immune cells)
quantification of Tregs, MDSC, MAIT, T lymphocytes
Measured: Day 15, Day 30, Day 60, Day 90, Day 180, Year 1, Year 2
GVH disease
yes/not
Measured: Day 30, Day 60, Day 90
use of antibiotics
yes/not (molecules, delay, posology)
Measured: Day 0, Day 15, Day 30, Day 60, Day 90
level of stress
test of Cohen
Measured: Day -8, Day 15, Day 30, Day 90
level of anxiety
test of Spielberger
Measured: Day -8, Day 15, Day 30, Day 90
quality of iNKT reconstitution after HSCT (good/poor)
Measured: Day 15, Day 30, Day 60, Day 180, Year 1, Year2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start4 Dec 2018
- Primary completion31 Jan 2021 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616015
- Sponsor's protocol ID
- 2018-A00676-49
- Acronym
- PARI-DYS
- Status last verified
- Jan 2019
- First submitted
- 19 Jul 2018
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Dysbiosis and Immune Reconstitution After Allogeneic Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT03616015
- Acronym / sponsor ID
- PARI-DYS / 2018-A00676-49
- Conditions
- Hematopoietic Stem Cell Transplantation
- Keywords
- HSCT, intestinal dysbiosis, immune reconstitution
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | Experimental | Biological: blood samples, Biological: fecal samples, Behavioral: Anxiety test, Behavioral: Stress testFor 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- HIV+ patients
- Patients with active HBV or HCV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samples20 to 30 ml of blood sample (D0, D15, D30, D60, D90, D180, Y1, Y2) | Biological | Patient |
| fecal samples1 g of feces (D-8, D0, D15, D30, D90) | Biological | Patient |
| Anxiety testTest of Spielberger | Behavioural | Patient |
| Stress testTest of Cohen | Behavioural | Patient |
Primary outcome
quality of iNKT reconstitution after HSCT (good/poor)
Time frame: Day 90,
7 secondary outcomes
gut microbiota composition
Time frame: Day 0, Day 15, Day 30, Day 90
immune reconstitution after HSCT (other immune cells)
Time frame: Day 15, Day 30, Day 60, Day 90, Day 180, Year 1, Year 2
GVH disease
Time frame: Day 30, Day 60, Day 90
use of antibiotics
Time frame: Day 0, Day 15, Day 30, Day 60, Day 90
level of stress
Time frame: Day -8, Day 15, Day 30, Day 90
level of anxiety
Time frame: Day -8, Day 15, Day 30, Day 90
quality of iNKT reconstitution after HSCT (good/poor)
Time frame: Day 15, Day 30, Day 60, Day 180, Year 1, Year2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood samples, fecal samples and Anxiety test in people with Hematopoietic Stem Cell Transplantation, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Corentine ALAUZET, Dr (0383153938 ext. +33, c.alauzet@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of iNKT reconstitution after HSCT (good/poor) (time frame: Day 90,). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2019.