Characterization of Pulmonary Microbiome in Cystic Fibrosis Patients

• Conditions: Cystic Fibrosis

• Registration Number: NCT04735679
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

The composition and role of the pulmonary microbiota is not yet well described in cystic fibrosis patients.

The objective of our longitudinal follow-up of primary colonised patients is to show the presence of a link between the composition of the microbiota and the effectiveness of antibiotic therapy.

All patients followed at the Montpellier CF center will be asked to participate in this cohort. All patients have a regular follow-up every 1 to 6 months and will be asked at each visit to keep their sputum sample in excess of the analyses requested for their follow-up

Detailed Description

The composition and role of the pulmonary microbiota is not yet well described in cystic fibrosis patients.

According to our hypothesis, the lung microbiota shapes the lung environment of cystic fibrosis patients and modifies the effectiveness of antibiotic treatments and the course of the disease. The objective of our longitudinal follow-up of primary colonised patients is to show the presence of a link between the composition of the microbiota and the effectiveness of antibiotic therapy. Finally, the management of first colonisations could justify the characterisation of the microbiota in order to develop innovative diagnostic tests for the follow-up of patients suffering from cystic fibrosis and possibly the identification of new therapeutic agents based on the microbiota.

All patients followed at the Montpellier CF centre will be asked to participate in this cohort. All patients have a regular follow-up every 1 to 6 months and will be asked at each visit to keep their sputum sample in excess of the analyses requested for their follow-up.

Study Timeline

• Status Verified: 2021-01
• Study Start: 2021-01-01
• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-01-29
• Last Update Submitted: 2021-02-02
• Study First Posted: 2021-02-03
• Last Update Posted: 2021-02-05
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to determine a characterisation of the microorganisms of the lung microbiota	1 day	to characterise the microorganisms of the lung microbiota and their interspecific interactions by taxonomic and functional analyses.
to determine a ink between the Composition of the microbiota	1 day	To demonstrate the relationship between the composition of the microbiota and the evolution of the disease Defines the effectiveness of anti-inflammatory biotherapy in patients with cystic fibrosis
to determine a Effectiveness of antibiotic therapy	1 day	To identify abiotic conditions that may contribute to the gap between the efficacy of antibiotics in vitro and in vivo.; Show that the microbiota plays a role in the effectiveness of antibiotic treatment.

Trial Locations

Locations (1)

Uh Montpellier; 🇫🇷 Montpellier, France