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Observational Study on Highly Effective Modulator Therapy and the CF Microbiome

This observational study is looking at how highly effective modulator therapy, a specific treatment for cystic fibrosis (CF), affects the bacteria in your nose and sinuses. Researchers want to understand if this therapy changes the types of bacteria present, reduces inflammation in these areas, and improves your sense of smell and overall quality of life. You might be able to join if you are an adult (18-99 years old) with CF, speak English, and are a patient at the New Hampshire Cystic Fibrosis Center. The study aims to enroll 30 participants. Success for this study would mean seeing positive changes in nasal bacterial communities and inflammatory markers in those receiving the therapy.

Study design
This is an observational study, meaning researchers will watch and collect information without giving you a specific treatment. It plans to enroll 30 participants.
What's involved
You would have five research visits over two years (at baseline, 6, 12, 18, and 24 months). These visits involve a nasal endoscopy (a thin tube with a camera to look inside your nose) to collect mucus, a smell test, and completing two surveys about your quality of life.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 months, with measurements taken at baseline, 6, 12, 18, and 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05982795

Impact of Highly Effective Modulator Therapy on the Cystic Fibrosis Microbiome

Recruiting
Not specifiedAges 18–99Observational
Dartmouth-Hitchcock Medical Center
~30 participants
Updated 2025-12-16 on ClinicalTrials.gov
What's tested:Nasal endoscopy with microbiome swab and mucus collection through filter paper and spongeOlfactory Function TestingSurvey Completion

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Difference in nasal bacterial community composition between CFTR-MT cohort and Non-CFTR-MT cohort
Measured over Baseline, 6 months, 12 months, 18 months, 24 months
+1 more outcome measured

Conditions

Cystic Fibrosis

Explore related trials

Cystic Fibrosis

Where it's being run

1 sites across 1 states
New Hampshire1

Study leadership

  • Ryan E Little, MD · PRINCIPAL_INVESTIGATOR · Dartmouth-Hitchcock Medical Center

Who to contact

Ryan E Little, MD
[email protected]
(603) 650 8123
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Subjects between the ages of 18 years old (inclusive) and 99 years old (inclusive)
English-speaking
Diagnosed with CF as established by genetic testing combined with clinical assessment and/or sweat chloride
Patients being seen at the New Hampshire Cystic Fibrosis Center
Adults able to sign informed consent

Exclusion

Adults unable to consent
Individuals who are not yet adults
Prisoners

What this trial measures

  • Difference in nasal bacterial community composition between CFTR-MT cohort and Non-CFTR-MT cohortBaseline, 6 months, 12 months, 18 months, 24 months

    Difference in microbial communities in mucus swabs between cystic fibrosis patients on CFTR-MT and cystic fibrosis patients not on CFTR-MT.

  • Difference in inflammatory profiles between CFTR-MT cohort and Non-CFTR-MT cohortBaseline, 6 months, 12 months, 18 months, 24 months

    Difference in microbiome swab cytokine assay results between cystic fibrosis patients on CFTR-MT and cystic fibrosis patients not of CFTR-MT.