Development of an Atlas of Respiratory Host-microbiome Interactions in Healthy Volunteers (HEALTHY LUNG)

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Patients
• Intervention / Treatment: Other: Voluntary

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France
    • CHU de Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Voluntary; 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.	Other: Voluntary; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atlas of host-microbiome interactions	Healthy respiratory metacluster	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlations between bacterial species	To define the link between the patient and the bacterial transcriptional activities	Day 1
Correlations between bacterial species	To define the link between the patient and the bacterial composition	Day 1
Correlations between cell populations	To define the link between the patient and the transcriptional clusters of cell populations	Day 1
Correlations between metabolite concentrations	To define the link between the patient and the metabolite concentrations	Day 1
Correlations between protein concentrations	To define the link between the patient and the protein concentrations	Day 1
Correlations between host-microbiome interactions and quality of life scales	To define the link between the patient and different scales (MOCA, EPICES, modified MRC, NYHA, EQ5D-5L, SWLS, SF-36, HADS and BPI	Day 1

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2025
• Primary Completion (Actual): February 23, 2026
• Study Completion (Actual): March 4, 2026

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 18, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: RC24_0007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No