Epidemiology of Anaerobic Bacteria in Cystic Fibrosis Patients: Descriptive and Non-interventional Study (ANA-MUCO)

June 28, 2021 updated by: University Hospital, Brest

Epidemiology of Anaerobic Bacteria in Cystic Fibrosis Patients Followed by the Perharidy Cystic Fibrosis Resource and Skills Centre, Roscoff: Descriptive and Non-interventional Study

Recently, the respiratory microbiota characterisation of a Cystic Fibrosis (CF) patients' cohort has highlighted the potential role of anaerobes, and specially species belonging to the genus Porphyromonas, in the first P. aeruginosa colonization.

The aim of this project is to describe the bacterial anaerobic population in the respiratory microbiota of a CF cohort. At the end of this study, an inventory of the anaerobic microbiota in CF respiratory samples will be establish in relation to the patients' pulmonary function and P. aeruginosa colonization status in order to speculate about the pulmonary anaerobes roles, still unknown.

The innovative aspect of the ANA-MUCO study is the use of a specific sample kit designed for the study which allows preserving anaerobic bacteria in sputum according to the recommendations of the International Human Microbiome Standards (IHMS). Extended-culture and molecular approaches will be performed to identify and describe the anaerobic bacteria which could be involved in the pulmonary homeostasis in CF respiratory samples.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cystic Fibrosis (CF) is a lethal genetic disease whose prognostic depends on the patients' respiratory impairment. Indeed, the airways microbial chronic colonization, particularly to Pseudomonas aeruginosa, leads to infectious exacerbations and to noteworthy respiratory function impairment and represents the main cause of morbidity and mortality. Nowadays, antibiotherapy is the main therapeutic solution to thwart bacterial development and to slow respiratory function degradation. However, during the disease progression, this therapeutical approach is limited by the bacteria accommodation and antibiotic resistance development.

Thanks to the development of high-throughput sequencing methods, the respiratory microbiota of CF patients has been mainly described and points the way to new therapeutic approaches. It has been establish that, i) from an early age, the respiratory microbiota of CF children is modified in comparison with the healthy children one, ii) bacterial diversity decrease progressively throughout the disease evolution, iii) anaerobes represent an important part of the healthy and CF respiratory microbiota. Thus pulmonary microbiota composition could be a better disease progression indicator than the only detection of P. aeruginosa in CF respiratory samples. Furthermore, the respiratory microbiota could influence the pathogenesis through direct interactions between micro-organism/micro-organism or micro-organism/host. Recently, thanks to the respiratory microbiota characterisation of a CF patients' cohort (MUCOBIOME study, 2012-2015), the potential role of anaerobes (and particularly species belonging to the genus Porphyromonas) in the first P. aeruginosa colonization has been highlighted. Indeed, the respiratory microbiota study of 34 CF patients has revealed that if patients are deprived or lowly colonized by Porphyromonas spp., the relative risk of P. aeruginosa colonization is 3.7 fold higher. Conversely, the relative abundance's increase of Porphyromonas spp. in CF patients receiving Ivacaftor treatment is correlated with the respiratory function improvement. Thus, in addition to be used as biomarker, the investigators speculate on the fact that some strict anaerobic species, such as Porphyromonas spp., could act as CF pathogens (like P. aeruginosa) competitors and limit their setting up in the airways.

The investigators see here the necessity of complementary studies in order to better characterise anaerobic bacteria in the airways. The aim of the ANA-MUCO study is to identify and describe anaerobic bacteria in sputum of a CF patients' cohort, to characterise the antibiotic resistance profiles of the anaerobic species isolated, to study the anaerobes repartition within the CF population and to evaluate the interactions between anaerobes and CF pathogens (P. aeruginosa, S. aureus, H. influenzae, …). In order to be the most exhaustive as possible in the anaerobes description, the innovative aspect of this study is the conception and the use of a specific sample kit which preserves anaerobic conditions in sputum according to the recommendations of the International Human Microbiome Standards (IHMS). Then, extended-culture and molecular approaches will be performed to identify the anaerobic bacteria which could be involved in the pulmonary homeostasis in CF respiratory samples.

Study Type

Observational

Enrollment (Actual)

101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29609
        • CHRU de Brest
      • Roscoff, France, 29250
        • Fondation Ildys

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cystic Fibrosis patients

Description

Inclusion Criteria:

  • Patients with a confirmed diagnosis of Cystic Fibrosis regardless of CFTR genotype
  • Persons affiliated to the social security system
  • Minor or major patients able to expectorate spontaneously or after induction
  • Consent signed by the patient or the holder of parental authority for the children

Exclusion Criteria:

  • Persons deprived of liberty, persons under guardianship or curatorship, persons in emergency situations
  • Persons non affiliated to a social security system or not entitled
  • Pulmonary transplant patients
  • Refusal to participate to the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cystic Fibrosis patients
Sputum samples
Other: Sputum samples
During consultation, one expectoration will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of anaerobic bacteria in sputum by culture and molecular approaches
Time Frame: Inclusion ( Day 0)
The presence of anaerobic bacteria will be evaluated by culture and molecular approaches with regard of the number of sputum collected.
Inclusion ( Day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Collaborators

Vaincre la Mucoviscidose

Investigators

  • Principal Investigator: Geneviève HERY-ARNAUD, Professor, University Hospital, Brest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2018

Primary Completion (Actual)

October 5, 2018

Study Completion (Actual)

October 5, 2018

Study Registration Dates

First Submitted

February 11, 2021

First Submitted That Met QC Criteria

May 6, 2021

First Posted (Actual)

May 10, 2021

Study Record Updates

Last Update Posted (Actual)

June 30, 2021

Last Update Submitted That Met QC Criteria

June 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANA-MUCO ( 29BRC18.0045)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data that underlie results in a publication.

IPD Sharing Time Frame

Data will be available after the publication of result and ending fifteen years following the last visit of the last patient.

IPD Sharing Access Criteria

Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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