๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-12-09

Impact of Highly Effective Modulator Therapy on the Cystic Fibrosis Microbiome (NCT05982795)

Impact of Highly Effective Modulator Therapy on Sinonasal Microbial Communities, Host Mucosal Inflammatory Environment and Quality of Life in Adults With Cystic Fibrosis

๐ŸŸข Recruiting Interventional Protocol ๐Ÿ“Š Observational Clinical Research Sponsor: Dartmouth-Hitchcock Medical Center

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The goal of this observational study is to learn about the effects of a specific cystic fibrosis therapy (Cystic Fibrosis Transmembrane Conductance Regulator Modulator Therapy) on chronic sinonasal disease. The main questions it aims to answer are: 1. How does this therapy impact bacterial communities in the paranasal sinuses? 2. How does this therapy impact inflammation in the paranasal sinuses and olfactory cleft? 3. How does this therapy impact sense of smell and sinonasal disease burden in individuals with cystic fibrosis? 4. How does this therapy impact disease-specific and general quality of life of individuals with cystic fibrosis? Participants will be asked to provide samples from their nose, complete testing of their sense of smell, and complete surveys about their quality of life and sense of smell in this study. Researchers will compare study results between patients who are currently undergoing Cystic Fibrosis Transmembrane Conductance Regulator Modulator Therapy and patients who are not currently undergoing therapy.

Who can join: Review the eligibility criteria below.

Location: Dartmouth-Hitchcock Medical Center โ€” Lebanon, New Hampshire

Age range: 18 Years to 99 Years

๐Ÿงช Interventions in This Study

  • Nasal endoscopy with microbiome swab and mucus collection through filter paper and sponge (OTHER)
  • Olfactory Function Testing (OTHER)
  • Survey Completion (OTHER)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Dartmouth-Hitchcock Medical Center โ€” Lebanon, New Hampshire

๐Ÿ“ž Contact the Study Coordinator

Phone: (603) 650-8123

Email: Ryan.E.Little@hitchcock.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Cystic Fibrosis clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—