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Development of an Atlas of Respiratory Host-microbiome Interactions in Healthy Volunteers

Développement d'un Atlas Des Interactions hôte-microbiome Respiratoire Chez Des Volontaires Sains

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06518161
Acronym
HEALTHY LUNG
Enrollment
82
Registered
2024-07-24
Start date
2025-01-03
Completion date
2026-03-04
Last updated
2026-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Patients

Brief summary

The role of the pulmonary microbiome in the pathophysiology of lung disease is becoming increasingly well understood. Studies on murine models have highlighted the immunomodulatory and antibacterial activity of certain commensal bacteria, such as S. mitis, and have led to an understanding of their potential therapeutic impact. The investigators will therefore couple their analyses of the respiratory microbiome with an in-depth analysis of mucosal immunity. In particular, they will characterize immune cell types and frequencies using high-dimensional (spectral) flow cytometry and single cell RNA-sequencing. Finally, they will study the mediators exchanged between the microbiome and the host using proteomic and metabolomic analyses of respiratory fluids.

Interventions

OTHERVoluntary

Subjects undergoing scheduled surgery in the operating room at Nantes University Hospital, requiring general anesthesia with placement of an endotracheal intubation tube for invasive mechanical ventilation.

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Male or female. * Age from 18 to 70. * Indication for scheduled general anesthesia with orotracheal intubation for non-thoracic, non-carcinological, non-septic surgical procedures such as prosthesis (knee or hip), spinal surgery, digestive hernia surgery, gall bladder surgery, maxillofacial surgery (non-exhaustive list). * Membership of a social security scheme or beneficiary of such a scheme. * Written informed consent.

Exclusion criteria

* Persons under guardianship or trusteeship. * Pregnant or breast-feeding woman. * Antibiotic treatment received within 28 days prior to surgery, regardless of the site of infection. * Acute respiratory pathology within the last 28 days (pneumothorax, bronchitis or pneumonia including Covid). * History of chronic respiratory disease (asthma, chronic obstructive pulmonary disease, emphysema, lung cancer, cystic fibrosis, etc.). * Immunosuppression (cancer active or within the last 5 years, HIV, radio-chemotherapy within the last year, organ transplant). * Chronic inflammatory disease (digestive, osteoarticular, neurological or cutaneous) requiring or having required specific treatment in the last 12 months. * Type I or II diabetes. * Steroid treatment within the last 30 days (regardless of dose or duration).

Design outcomes

Primary

MeasureTime frameDescription
Atlas of host-microbiome interactions1 dayHealthy respiratory metacluster

Secondary

MeasureTime frameDescription
Correlations between bacterial speciesDay 1To define the link between the patient and the bacterial transcriptional activities
Correlations between cell populationsDay 1To define the link between the patient and the transcriptional clusters of cell populations
Correlations between metabolite concentrationsDay 1To define the link between the patient and the metabolite concentrations
Correlations between protein concentrationsDay 1To define the link between the patient and the protein concentrations
Correlations between host-microbiome interactions and quality of life scalesDay 1To define the link between the patient and different scales (MOCA, EPICES, modified MRC, NYHA, EQ5D-5L, SWLS, SF-36, HADS and BPI

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026