Effects of Modulator Therapy on Cystic Fibrosis Microbiome
Impact of Highly Effective Modulator Therapy on Sinonasal Microbial Communities, Host Mucosal Inflammatory Environment and Quality of Life in Adults With Cystic Fibrosis
This study is trying to see how a new treatment for cystic fibrosis affects the bacteria in the sinuses and overall health of adults with the condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Dartmouth-Hitchcock Medical Center Academic / other |
| Locations | 1 site (Lebanon, New Hampshire) |
| Trial ID | NCT05982795 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate how Cystic Fibrosis Transmembrane Conductance Regulator Modulator Therapy affects the microbiome and inflammation in the paranasal sinuses of adults with cystic fibrosis. Participants will provide nasal samples, undergo olfactory function testing, and complete surveys regarding their quality of life and sense of smell over a two-year period with five research visits. The study will analyze bacterial communities and inflammatory profiles to understand the therapy's impact on sinonasal disease and overall health.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 99 diagnosed with cystic fibrosis who are English-speaking and able to provide informed consent.
Not a fit: Patients who are unable to consent or are under 18 years old will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of how modulator therapy improves sinonasal health and quality of life for cystic fibrosis patients.
How similar studies have performed: While similar studies on cystic fibrosis therapies exist, this specific focus on the sinonasal microbiome and inflammation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Adults unable to consent * Individuals who are not yet adults * Prisoners
Where this trial is running
Lebanon, New Hampshire
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (Recruiting)
Study contacts
- Principal investigator: Ryan E Little, MD — Dartmouth-Hitchcock Medical Center
- Study coordinator: Ryan E Little, MD
- Email: Ryan.E.Little@hitchcock.org
- Phone: (603) 650 8123
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.