Development of an Atlas of Respiratory Host-microbiome Interactions in Healthy Volunteers
- Conditions
- Healthy Patients
- Interventions
- Other: Voluntary
- Registration Number
- NCT06518161
- Lead Sponsor
- Nantes University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 75
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Voluntary 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.
- Primary Outcome Measures
Name Time Method Atlas of host-microbiome interactions 1 day Healthy respiratory metacluster
- Secondary Outcome Measures
Name Time Method Correlations between bacterial species Day 1 To define the link between the patient and the bacterial composition
Correlations between cell populations Day 1 To define the link between the patient and the transcriptional clusters of cell populations
Correlations between metabolite concentrations Day 1 To define the link between the patient and the metabolite concentrations
Correlations between protein concentrations Day 1 To define the link between the patient and the protein concentrations
Correlations between host-microbiome interactions and quality of life scales 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
Trial Locations
- Locations (2)
CHU de Nantes
🇫🇷Nantes, France
CHU de Nantes
🇫🇷Nantes, France