Cystic FibrosisBEACHNCT03947957
Microbial Biomarkers of EArly Pseudomonas Aeruginosa Colonization in CHildren With Cystic Fibrosis
A study testing collection of expectoration, stools and blood in people with Cystic Fibrosis, run by University Hospital, Brest at 11 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 6 months
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- collection of expectoration, stools and blood
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 11 sitesFrance
- Study dates
- 2 Oct 2020to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
CHRU Angers
Angers
Hôpital des Enfants Bordeaux
Bordeaux
CHU Grenoble
Grenoble
Hôpital Femme-Mère-Enfant Lyon
Lyon
CHRU Nantes
Nantes
Hôpital Necker
Paris
Hôpital Trousseau
Paris
CHRU Rennes
Rennes
Centre de Perharidy
Roscoff
Hôpital Charles Nicolle
Rouen
CHRU de Tours
Tours
About this study
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.
Read the 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.
- Conditions
- Cystic Fibrosis
- Being tested
- collection of expectoration, stools and blood
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of expectoration, stools and bloodDiagnostic test
collection of expectoration, stools and blood
| Study group | Role | What they receive |
|---|---|---|
| collection of expectoration, stools and blood | Other | Not described Receives: Diagnostic Test: collection of expectoration, stools and blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of P. aeruginosa in bacterial sputum cultures collected at 36 months of age
positive or negative
Measured: 36 months
Secondary outcomes (11)
Absolute amount of P. aeruginosa at different sampling times.
amount (UFC/mL)
Measured: 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)
Measured: 36 months
Absolute amount of P. catoniae in stool at different sampling times and Delta between 12, 24 and 36 months.
amount (UFC/mL)
Measured: 36 months
Level of dysbiosis
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start2 Oct 2020
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (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, BrestThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Infants will be included between the 2nd visit to the CRCM (about 2 months of age) and the 6th month then they will be followed until the age of 36 months. The pace of visits will be based on the usual follow-up rate of CF infants.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Genevieve HERY-ARNAUD, Pr, Principal investigator, University Hospital, Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947957
- Sponsor's protocol ID
- BEACH (29BRC19.0065)
- Acronym
- BEACH
- Status last verified
- Jun 2026
- First submitted
- 10 May 2019
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbial Biomarkers of EArly Pseudomonas Aeruginosa Colonization in CHildren With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT03947957
- Acronym / sponsor ID
- BEACH / BEACH (29BRC19.0065)
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 13 May 2019 (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 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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Infants will be included between the 2nd visit to the CRCM (about 2 months of age) and the 6th month then they will be followed until the age of 36 months. The pace of visits will be based on the usual follow-up rate of CF infants.
| Arm | Type | Receives |
|---|---|---|
| collection of expectoration, stools and blood | Other | Diagnostic Test: collection of expectoration, stools and blood |
Who may qualify
- Ages
- 2 to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collection of expectoration, stools and bloodcollection of expectoration, stools and blood | Diagnostic test | collection of expectoration, stools and blood |
Primary outcome
Presence of P. aeruginosa in bacterial sputum cultures collected at 36 months of age
Time frame: 36 months
positive or negative
11 secondary outcomes
Absolute amount of P. aeruginosa at different sampling times.
Time frame: 36 months
Absolute amount of P. catoniae in respiratory secretions at different sampling times and Delta between 12, 24 and 36 months.
Time frame: 36 months
Absolute amount of P. catoniae in stool at different sampling times and Delta between 12, 24 and 36 months.
Time frame: 36 months
Level of dysbiosis
Time frame: 36 months
Pulmonary concentration of inflammatory markers
Time frame: 36 months
Number, diversity, and quality of antibiotic resistance genes
Time frame: 36 Months
Levels of blood metabolites
Time frame: 36 Months
Constitutional SNPs
Time frame: 36 Months
Breastfeeding at each visit
Time frame: 36 Months
Dietary diversification at each visit
Time frame: 36 Months
Treatments received at each visit
Time frame: 36 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
Genevieve HERY-ARNAUD, Pr principal investigator
University Hospital, Brest
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing collection of expectoration, stools and blood in people with Cystic Fibrosis, run by University Hospital, Brest at 11 sites 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 3 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of P. aeruginosa in bacterial sputum cultures collected at 36 months of age (time frame: 36 months). 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 16 Jun 2026.