Characterization of Pulmonary Microbiome in Cystic Fibrosis Patients

Cystic Fibrosis Clinical Trial

— SPutOM-CF  

Official title:

Multi-omic Longitudinal Characterization of Pulmonary Microbiome in Cystic Fibrosis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04735679
• Other study ID #: RECHMPL21_0053
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2021
• Source: University Hospital, Montpellier
• Contact: Raphael CHIRON, PU-PH
• Phone: 467336089
• Email: r-chiron[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 31, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria:

• Cystic fibrosis patient

Exclusion criteria

• Refusal to participate in this research

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Locations

Country	Name	City	State
France	Uh Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to determine a characterisation of the microorganisms of the lung microbiota	to characterise the microorganisms of the lung microbiota and their interspecific interactions by taxonomic and functional analyses.	1 day
Primary	to determine a ink between the Composition of the microbiota	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	1 day
Primary	to determine a Effectiveness of antibiotic therapy	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.	1 day