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Active, Not Recruiting

NCT Number: NCT03947957

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

2 month–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Angers, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

collection of expectoration, stools and blood

Diagnostic Test

collection of expectoration, stools and blood

Primary outcomes

  1. Presence of P. aeruginosa in bacterial sputum cultures collected at 36 months of age

    Time frame: 36 months

    positive or negative

Secondary outcomes

  1. Absolute amount of P. aeruginosa at different sampling times.

    Time frame: 36 months

    amount (UFC/mL)

  2. Absolute amount of P. catoniae in respiratory secretions at different sampling times and Delta between 12, 24 and 36 months.

    Time frame: 36 months

    amount (UFC/mL)

  3. Absolute amount of P. catoniae in stool at different sampling times and Delta between 12, 24 and 36 months.

    Time frame: 36 months

    amount (UFC/mL)

  4. Level of dysbiosis

    Time frame: 36 months

  5. Pulmonary concentration of inflammatory markers

    Time frame: 36 months

    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.

  6. Number, diversity, and quality of antibiotic resistance genes

    Time frame: 36 Months

    This objective aims to identify and analyze the antibiotic resistance genes present in pulmonary and intestinal samples from infants with cystic fibrosis.

  7. Levels of blood metabolites

    Time frame: 36 Months

    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

  8. Constitutional SNPs

    Time frame: 36 Months

    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

  9. Breastfeeding at each visit

    Time frame: 36 Months

    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.

  10. Dietary diversification at each visit

    Time frame: 36 Months

    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.

  11. Treatments received at each visit

    Time frame: 36 Months

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: BEACH

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
May 13, 2019
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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