RECRUITING

Impact of Highly Effective Modulator Therapy on the Cystic Fibrosis Microbiome

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-11-08
Study Completion:2026-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05982795

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects between the ages of 18 years old (inclusive) and 99 years old (inclusive)
  2. * English-speaking
  3. * Diagnosed with CF as established by genetic testing combined with clinical assessment and/or sweat chloride
  4. * Patients being seen at the New Hampshire Cystic Fibrosis Center
  5. * Adults able to sign informed consent
  1. * Adults unable to consent
  2. * Individuals who are not yet adults
  3. * Prisoners

Contacts and Locations

Study Contact

Ryan E Little, MD
CONTACT
(603) 650 8123
Ryan.E.Little@hitchcock.org
Michaela M Geffert, BS
CONTACT
michaela.m.geffert@hitchcock.org

Principal Investigator

Ryan E Little, MD
PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center

Study Locations (Sites)

Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States

Collaborators and Investigators

Sponsor: Dartmouth-Hitchcock Medical Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-08
Study Completion Date2026-12-01

Study Record Updates

Study Start Date2023-11-08
Study Completion Date2026-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Cystic Fibrosis