NCT04879381

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 29, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2018

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 10, 2021

Completed
Last Updated

June 30, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

February 11, 2021

Last Update Submit

June 28, 2021

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

  • Presence of anaerobic bacteria in sputum by culture and molecular approaches

    The presence of anaerobic bacteria will be evaluated by culture and molecular approaches with regard of the number of sputum collected.

    Inclusion ( Day 0)

Study Arms (1)

Cystic Fibrosis patients

Sputum samples

Other: Sputum samples

Interventions

Sputum samplesOTHER

During consultation, one expectoration will be performed.

Cystic Fibrosis patients

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cystic Fibrosis patients

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHRU de Brest

Brest, 29609, France

Location

Fondation Ildys

Roscoff, 29250, France

Location

Related Publications (15)

  • Nixon GM, Armstrong DS, Carzino R, Carlin JB, Olinsky A, Robertson CF, Grimwood K. Clinical outcome after early Pseudomonas aeruginosa infection in cystic fibrosis. J Pediatr. 2001 May;138(5):699-704. doi: 10.1067/mpd.2001.112897.

    PMID: 11343046BACKGROUND

  • Cox MJ, Allgaier M, Taylor B, Baek MS, Huang YJ, Daly RA, Karaoz U, Andersen GL, Brown R, Fujimura KE, Wu B, Tran D, Koff J, Kleinhenz ME, Nielson D, Brodie EL, Lynch SV. Airway microbiota and pathogen abundance in age-stratified cystic fibrosis patients. PLoS One. 2010 Jun 23;5(6):e11044. doi: 10.1371/journal.pone.0011044.

    PMID: 20585638BACKGROUND

  • Renwick J, McNally P, John B, DeSantis T, Linnane B, Murphy P; SHIELD CF. The microbial community of the cystic fibrosis airway is disrupted in early life. PLoS One. 2014 Dec 19;9(12):e109798. doi: 10.1371/journal.pone.0109798. eCollection 2014.

    PMID: 25526264BACKGROUND

  • Klepac-Ceraj V, Lemon KP, Martin TR, Allgaier M, Kembel SW, Knapp AA, Lory S, Brodie EL, Lynch SV, Bohannan BJ, Green JL, Maurer BA, Kolter R. Relationship between cystic fibrosis respiratory tract bacterial communities and age, genotype, antibiotics and Pseudomonas aeruginosa. Environ Microbiol. 2010 May;12(5):1293-303. doi: 10.1111/j.1462-2920.2010.02173.x. Epub 2010 Feb 23.

    PMID: 20192960BACKGROUND

  • Sibley CD, Surette MG. The polymicrobial nature of airway infections in cystic fibrosis: Cangene Gold Medal Lecture. Can J Microbiol. 2011 Feb;57(2):69-77. doi: 10.1139/w10-105.

    PMID: 21326348BACKGROUND

  • Bernarde C, Keravec M, Mounier J, Gouriou S, Rault G, Ferec C, Barbier G, Hery-Arnaud G. Impact of the CFTR-potentiator ivacaftor on airway microbiota in cystic fibrosis patients carrying a G551D mutation. PLoS One. 2015 Apr 8;10(4):e0124124. doi: 10.1371/journal.pone.0124124. eCollection 2015.

    PMID: 25853698BACKGROUND

  • Guilloux CA, Lamoureux C, Hery-Arnaud G. [Anaerobic bacteria, the unknown members of the lung microbiota]. Med Sci (Paris). 2018 Mar;34(3):253-260. doi: 10.1051/medsci/20183403014. Epub 2018 Mar 16. French.

    PMID: 29547112BACKGROUND

  • Tunney MM, Field TR, Moriarty TF, Patrick S, Doering G, Muhlebach MS, Wolfgang MC, Boucher R, Gilpin DF, McDowell A, Elborn JS. Detection of anaerobic bacteria in high numbers in sputum from patients with cystic fibrosis. Am J Respir Crit Care Med. 2008 May 1;177(9):995-1001. doi: 10.1164/rccm.200708-1151OC. Epub 2008 Feb 8.

    PMID: 18263800BACKGROUND

  • Smyth AR, Bell SC, Bojcin S, Bryon M, Duff A, Flume P, Kashirskaya N, Munck A, Ratjen F, Schwarzenberg SJ, Sermet-Gaudelus I, Southern KW, Taccetti G, Ullrich G, Wolfe S; European Cystic Fibrosis Society. European Cystic Fibrosis Society Standards of Care: Best Practice guidelines. J Cyst Fibros. 2014 May;13 Suppl 1:S23-42. doi: 10.1016/j.jcf.2014.03.010.

    PMID: 24856775BACKGROUND

  • Hery-Arnaud G, Nowak E, Caillon J, David V, Dirou A, Revert K, Munck MR, Frachon I, Haloun A, Horeau-Langlard D, Le Bihan J, Danner-Boucher I, Ramel S, Pelletier MP, Rosec S, Gouriou S, Poulhazan E, Payan C, Ferec C, Rault G, Le Gal G, Le Berre R. Evaluation of quantitative PCR for early diagnosis of Pseudomonas aeruginosa infection in cystic fibrosis: a prospective cohort study. Clin Microbiol Infect. 2017 Mar;23(3):203-207. doi: 10.1016/j.cmi.2016.11.016. Epub 2016 Nov 27.

    PMID: 27903460BACKGROUND

  • Lamoureux C, Guilloux CA, Beauruelle C, Jolivet-Gougeon A, Hery-Arnaud G. Anaerobes in cystic fibrosis patients' airways. Crit Rev Microbiol. 2019 Feb;45(1):103-117. doi: 10.1080/1040841X.2018.1549019. Epub 2019 Jan 21.

    PMID: 30663924BACKGROUND

  • Société Française de Microbiologie. REMIC, Référentiel en Microbiologie Médicale, 2 volumes. SFM, 2015. 856 p. ISBN 9782878050325.

    BACKGROUND

  • CA-SFM EUCAST [En ligne]. Société Française de Microbiologie, 2013 [consulté le 11 janvier 2018]. Available on: http://www.sfmmicrobiologie.org/UserFiles/files/casfm/CASFM2013vjuin.pdf

    BACKGROUND

  • Héry-Arnaud et al., 2017, European patent EP17306297 Methods for predicting the risk of developping pulmonary colonization/infection by Pseudomonas aeruginosa.

    BACKGROUND

  • Keravec M, Mounier J, Guilloux CA, Fangous MS, Mondot S, Vallet S, Gouriou S, Le Berre R, Rault G, Ferec C, Barbier G, Lepage P, Hery-Arnaud G. Porphyromonas, a potential predictive biomarker of Pseudomonas aeruginosa pulmonary infection in cystic fibrosis. BMJ Open Respir Res. 2019 Mar 12;6(1):e000374. doi: 10.1136/bmjresp-2018-000374. eCollection 2019.

    PMID: 30956802BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Sputum

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Geneviève HERY-ARNAUD, Professor

    University Hospital, Brest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2021

First Posted

May 10, 2021

Study Start

March 29, 2018

Primary Completion

October 5, 2018

Study Completion

October 5, 2018

Last Updated

June 30, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication.

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient.
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.

Locations

FR(2)