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Not yet recruitingNCT06639750VIREMIGUpdated Mar 18, 2026

Respiratory Microbioma and Respiratory Complications After Hematopoietic Stem Cell Transplantion

An observational study in Hematopoietic Stem Cell Transplantation, Microbioata and Respiratory Complications, sponsored by University Hospital, Caen. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-18.

Sponsored by University Hospital, Caen · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
All
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Study summary

Allogeneic haematopoietic stem cell transplantation (AHSCT) is a therapeutic resource for many haemopathies. The number of HSCTs has risen sharply in recent years due to the use of attenuated conditioning, which has increased the risk of non-haematological complications. Pulmonary pathologies are a frequent cause of complications following HSCA, both infectious and non-infectious(1,3,4).

Among these, late non-infectious pulmonary complications (LNIPC), all taken together, occur in 25% of post-HSCA cases(1). These NIPCs, the most common of which is bronchiolitis obliterans, significantly alter the prognosis(4,5). The pathophysiology of CPTNI is poorly understood, but it seems that the occurrence of a viral respiratory infection (pre- or post-ACSH) may be a potential trigger for the onset of CPTNI(1). These viral infections can become "chronic", given that viral clearance is impaired by the underlying immunodepression, and can thus cause chronic inflammation leading to the fibrosing and irreversible process of obliterative bronchiolitis(6). Given the prognostic importance of this type of CPTNI, it seems essential to gain a better understanding of its pathophysiology, which may involve a number of mechanisms: cellular expression of the graft and its evolution, disruption of the host response (innate immunity) following viral infection, influence of the microbiome and alteration of epithelial repair(1,3,5). Interest in the digestive and respiratory microbiome has been growing in recent years(7-9). The literature is gradually being enriched with data on the links between infection, the microbiome and chronic respiratory pathology and, in the post-HSCA context, a potential link between the enteric microbiome and Chronic Graft Versus Host Disease (cGVHD).

A pilot study comparing respiratory microbiomes using sequencing and metatranscriptomic analysis on 20 respiratory samples (nasopharyngeal swab and bronchoalveolar lavage pairs) taken under the conditions of the proposed study showed that the technique was highly feasible and highly sensitive.

The aim of this study is therefore to use meta-genomics to investigate the respiratory virome/microbiome in a population of patients who have undergone HSCA: eukaryotic and prokaryotic viruses, bacterial expression and the expression (meta-transcriptomics) of graft-derived cell lines and their possible association with the occurrence of post-HSCA respiratory complications (infectious and non-infectious).

No study has assessed the link between the composition of the respiratory virome/microbiome and the occurrence of respiratory events (infectious and CPTNI post ACSH), but also more broadly the link with the composition of the microbiome in the broad sense (respiratory virome, respiratory and digestive microbiota).

The aim of this study is to establish a respiratory viral and bacterial map as a possible biomarker of the occurrence of respiratory events (infectious and CPTNI), thus enabling more personalised monitoring of patients at risk of CPTNI and management of immunosuppressive treatment of patients at risk of an infectious episode, with risk assessment based on the composition of the respiratory virome.

The interest of this study is that it is multidisciplinary and transdisciplinary, studying the respiratory pathologies and infections of haematology patients and combining clinical and fundamental research, with expected spin-offs for direct patient care (personalised monitoring and management of immunosuppressive treatments).

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Conditions studied

  • Hematopoietic Stem Cell Transplantation
  • Microbioata
  • Respiratory Complications
03

In context

Lead sponsor

University Hospital, Caen is the lead sponsor of 505 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All adult patients receiving an allogeneic hematopoietic stem cell transplant, whatever the underlying pathology.

Inclusion criteria

  • Male or female, aged 18 or over
  • French-speaking
  • Followed in the centre's haematology department with a project for a haematopoietic stem cell allograft
  • Whatever the haemopathy, previous treatments, type of transplant (pheno, geno, haplo-identical), type of graft (bone marrow, peripheral stem cells, cord blood), any conditioning (myeloablative or non-myeloablative), any immunosuppressive protocol.
  • Be affiliated to the social security system
  • Person able to understand the information and sign the consent form.
  • Informed consent must be collected and signed

Exclusion criteria

Exclusion Criteria:

  • Refusal to take part in the research
  • Failure to sign the consent form
  • Contraindication to nasopharyngeal swabbing
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. respiratory complications

    Time frame: From enrollment to the end of follow up at 2 years after HSCT

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Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06639750
Lead sponsor
University Hospital, Caen
Responsible party
Sponsor
First posted
Oct 15, 2024
Start date
Apr 1, 2026 (estimated)
Primary completion
Apr 1, 2028 (estimated)
Completion
Apr 1, 2030 (estimated)
Last update
Mar 18, 2026

Study contacts

Frédéric Rivière, M.D, Ph.D
Contact
riviere-f@chu-caen.fr
33+(0)231063106
Meriadeg Le Gouil, Ph.D
Contact
meriadeg.legouil@unicaen.fr

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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