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

NCT ID: NCT06518161

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-03

Study Completion Date

2027-07-01

Brief Summary

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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

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Conditions

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Healthy Patients

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Voluntary

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Nantes

Nantes, , France

Site Status RECRUITING

CHU de Nantes

Nantes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Antoine Roquilly

Role: CONTACT

0253482840 ext. +33

Astrid Garreau

Role: CONTACT

Facility Contacts

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Antoine ROQUILLY

Role: primary

+33253482230

Alexandre BERGIS

Role: primary

+33276643817

Other Identifiers

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RC24_0007

Identifier Type: -

Identifier Source: org_study_id

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