Cystic FibrosisSPutOM-CFNCT04735679
Characterization of Pulmonary Microbiome in Cystic Fibrosis Patients
An observational study of Cystic Fibrosis, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cystic fibrosis patients
Who may be able to join
- Cystic fibrosis patient
Who cannot join
- Refusal to participate in this research
Trial locations and contacts
1 site in 1 country.
Alexandre COUDRAT contact
France1 site, 1 recruiting
- Recruiting
Uh Montpellier
Montpellier, 34295
RAPHAEL CHIRON, PU-PH, 467336089 ext. 33, r-chiron@chu-montpellier.fr
Alexandre Coudrat, 467335937 ext. 33, alexandre-coudrat@outlook.fr
About this study
Official title: Multi-omic Longitudinal Characterization of Pulmonary Microbiome in Cystic Fibrosis Patients
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
Read the 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.
- Conditions
- Cystic Fibrosis
- Keywords
- MICROBIOLOGY, MULTI-OMIC, SPUTUM, PULMONARY MICROBIOTA, CYSTIC FIBROSIS, COHORT, ANTIBIOTHERAPY
- Medical subject headings
- Cystic Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
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
Measured: 1 day
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start1 Jan 2021
- Primary completion1 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raphael CHIRON, PU-PH, Principal investigator, University Hospitals of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735679
- Sponsor's protocol ID
- RECHMPL21_0053
- Acronym
- SPutOM-CF
- Status last verified
- Jan 2021
- First submitted
- 29 Jan 2021
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-omic Longitudinal Characterization of Pulmonary Microbiome in Cystic Fibrosis Patients
- ClinicalTrials.gov ID
- NCT04735679
- Acronym / sponsor ID
- SPutOM-CF / RECHMPL21_0053
- Conditions
- Cystic Fibrosis
- Keywords
- MICROBIOLOGY, MULTI-OMIC, SPUTUM, PULMONARY MICROBIOTA, CYSTIC FIBROSIS, COHORT, ANTIBIOTHERAPY
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cystic fibrosis patients
Key inclusion criteria (1 listed)
- Cystic fibrosis patient
Key exclusion criteria (1 listed)
- Refusal to participate in this research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
to determine a characterisation of the microorganisms of the lung microbiota
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre COUDRAT contact
Raphael CHIRON, PU-PH principal investigator
University Hospitals of Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raphael CHIRON, PU-PH (467336089 ext. 33, r-chiron@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to determine a characterisation of the microorganisms of the lung microbiota (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021.