Microbial Biomarkers of EArly Pseudomonas Aeruginosa Colonization in CHildren With Cystic Fibrosis (BEACH)

The objective of this study is to evaluate the predictive nature of the biomarker Porphyromonas catoniae measured at the age of 12 months in the occurrence of colonization with Pseudomonas aeruginosa at 36 months of age in children with cystic fibrosis.

Study Overview

• Status: Active, not recruiting
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Diagnostic test: collection of expectoration, stools and blood

Detailed Description

This is a multicentric study in 3 phases:

• Pre-inclusion: at the first visit to the CRCM (support for a positive screening confirmed by sweat test and genotyping CFTR)
• Inclusion: possible between the 2nd visit to the CRCM (about 2 months old) and the 6th month
• Follow-up: up to 36 months old. The pace of visits will be based on the usual follow-up rate of CF infants

The clinical data as well as samples (expectorations, stools) will be collected on a monthly basis up to 6 months old and then every 2 months until one year old and finally quarterly until 3 years old.

• Tracheo-bronchial secretions will be collected at the CRCM
• Stools samples will be carried out by the parents prior to consultation with the CRCM
• A blood collection will be carried out annually in an annual report.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France
    • CHRU Angers
  • Bordeaux, France
    • Hôpital des Enfants Bordeaux
  • Grenoble, France
    • CHU Grenoble
  • Lyon, France
    • Hôpital Femme-Mère-Enfant Lyon
  • Nantes, France
    • CHRU Nantes
  • Paris, France
    • Hôpital Trousseau
  • Paris, France
    • Hopital Necker
  • Rennes, France
    • CHRU Rennes
  • Roscoff, France
    • Centre de Perharidy
  • Rouen, France
    • Hôpital Charles Nicolle
  • Tours, France
    • CHRU de Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 6 months (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• Infants aged 6 months maximum at inclusion with a confirmed diagnosis of cystic fibrosis in its classical form (positive sweat test and/or two mutations of the CFTR gene from class I to III) -Children free from any antecedent of colonization to P. aeruginosa at the time of inclusion (certified by the microbiological history supplemented by a molecular test by qPCR according to the diagram of Le gal et al., 2013)---
• Affiliation to the social security system
• Consent signed by the holders of parental authority or the sole parent holding parental authority / and "oral" agreement of the second holder

Exclusion criteria:

• Severe acute illness (other than cystic fibrosis) ongoing, or requiring surgery
• Children unable to undergo the tests required by the protocol
• Children whose parent(s) is/are minors
• Children whose legal guardians do not have sufficient command of the French language
• Children under exclusive parenteral nutrition
• Refusal to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: collection of expectoration, stools and blood	Diagnostic test: collection of expectoration, stools and blood; collection of expectoration, stools and blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of P. aeruginosa in bacterial sputum cultures collected at 36 months of age	positive or negative	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of dysbiosis		36 months
Absolute amount of P. aeruginosa at different sampling times.	amount (UFC/mL)	36 months
Absolute amount of P. catoniae in respiratory secretions at different sampling times and Delta between 12, 24 and 36 months.	amount (UFC/mL)	36 months
Absolute amount of P. catoniae in stool at different sampling times and Delta between 12, 24 and 36 months.	amount (UFC/mL)	36 months
Pulmonary concentration of inflammatory markers	This objective aims to measure the concentration of inflammatory markers in pulmonary secretions collected from infants with cystic fibrosis during follow-up. The goal is to characterize the intensity and dynamics of the local inflammatory response and to relate these data to the evolution of the respiratory microbiota.	36 months
Number, diversity, and quality of antibiotic resistance genes	This objective aims to identify and analyze the antibiotic resistance genes present in pulmonary and intestinal samples from infants with cystic fibrosis.	36 Months
Levels of blood metabolites	This objective aims to measure the levels of blood metabolites in infants with cystic fibrosis throughout follow-up. The purpose is to characterize the metabolic profile associated with disease progression	36 Months
Constitutional SNPs	This objective aims to analyze constitutional single nucleotide polymorphisms (SNPs) in infants with cystic fibrosis. The goal is to explore host genetic variations that may influence susceptibility to early Pseudomonas aeruginosa colonization	36 Months
Breastfeeding at each visit	This objective aims to document breastfeeding status at each follow-up visit in infants with cystic fibrosis. The purpose is to assess the potential impact of breastfeeding on microbiota composition, immune and inflammatory responses, and the risk of early Pseudomonas aeruginosa colonization.	36 Months
Dietary diversification at each visit	This objective aims to record dietary diversification at each follow-up visit in infants with cystic fibrosis. The goal is to evaluate the influence of nutritional diversification on gut and respiratory microbiota composition, inflammatory and metabolic profiles, and the risk of early Pseudomonas aeruginosa colonization.	36 Months
Treatments received at each visit	This objective aims to document all treatments received at each follow-up visit in infants with cystic fibrosis, including antibiotics, CFTR modulators, and other relevant therapies.	36 Months

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Genevieve HERY-ARNAUD, Pr, University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2020
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: May 10, 2019
• First Submitted That Met QC Criteria: May 10, 2019
• First Posted (Actual): May 13, 2019

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Respiratory Tract Diseases; Digestive System Diseases; Lung Diseases; Infant, Newborn, Diseases; Pancreatic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cystic Fibrosis; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Defecation; Blood Specimen Collection
• Other Study ID Numbers: BEACH (29BRC19.0065)

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
• product manufactured in and exported from the U.S.: No