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Completed

NCT Number: NCT06518161

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

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.

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Key information

Conditions

Healthy Patients

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nantes

Nantes, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Voluntary

Other

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.

Primary outcomes

  1. Atlas of host-microbiome interactions

    Time frame: 1 day

    Healthy respiratory metacluster

Secondary outcomes

  1. Correlations between bacterial species

    Time frame: Day 1

    To define the link between the patient and the bacterial transcriptional activities

  2. Correlations between bacterial species

    Time frame: Day 1

    To define the link between the patient and the bacterial composition

  3. Correlations between cell populations

    Time frame: Day 1

    To define the link between the patient and the transcriptional clusters of cell populations

  4. Correlations between metabolite concentrations

    Time frame: Day 1

    To define the link between the patient and the metabolite concentrations

  5. Correlations between protein concentrations

    Time frame: Day 1

    To define the link between the patient and the protein concentrations

  6. Correlations between host-microbiome interactions and quality of life scales

    Time frame: Day 1

    To define the link between the patient and different scales (MOCA, EPICES, modified MRC, NYHA, EQ5D-5L, SWLS, SF-36, HADS and BPI

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: HEALTHY LUNG

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2024
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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