Mapping the interactions between the respiratory microbiome and the immune system in healthy individuals
Développement d'un Atlas Des Interactions hôte-microbiome Respiratoire Chez Des Volontaires Sains
This study is trying to see how the germs in the lungs interact with the immune system in healthy people to better understand lung health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Nantes and 1 other locations) |
| Trial ID | NCT06518161 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the interactions between the pulmonary microbiome and the immune system in healthy volunteers. Researchers will analyze the respiratory microbiome alongside immune cell types and frequencies using advanced techniques such as spectral flow cytometry and single-cell RNA sequencing. Additionally, they will investigate the mediators exchanged between the microbiome and the host through proteomic and metabolomic analyses of respiratory fluids. The goal is to enhance understanding of how these interactions may influence lung health.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 to 70 who are scheduled for non-thoracic surgical procedures requiring general anesthesia.
Not a fit: Patients with a history of chronic respiratory diseases or recent acute respiratory pathologies will not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to new insights into lung health and potential therapeutic strategies for respiratory diseases.
How similar studies have performed: While studies on the microbiome's role in health are emerging, this specific approach to mapping respiratory host-microbiome interactions is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Nantes and 1 other locations
- CHU de Nantes — Nantes, France (Recruiting)
- CHU de Nantes — Nantes, France (Recruiting)
Study contacts
- Study coordinator: Antoine Roquilly
- Email: antoine.roquilly@univ-nantes.fr
- Phone: 0253482840
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.