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New study aims to uncover muscle health secrets in cystic fibrosis

NCT ID NCT05639556

Knowledge-focused Sponsor: Jaeb Center for Health Research Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is measuring body composition, muscle strength, and nutrition in 300 adults with cystic fibrosis. Researchers are comparing simple tests like grip strength and walking distance to a standard body scan. The goal is to find better ways to track health and guide future treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors better assess nutrition and muscle health in people with cystic fibrosis, leading to improved care.
What could go wrong
This is an observational study, not a treatment trial. It will not directly improve health, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will include adults 18 and older with a confirmed diagnostic of cystic fibrosis, identified genotypes (when available), no prior solid organ transplant, and not pregnant or planning on becoming pregnant during the 1st year of the study. Participants receiving a lung transplantation while enrolled in the study will not need to be withdrawn.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Cohort 1: Participants are eligible if their percentage of predicated forced expiratory volume in 1 second (ppFEV1) is \<70% during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation) * Cohort 2: Participants are eligible if their percentage of predicted forced expiratory volume in 1 second (ppFEV1) is 70% or greater during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation). * Both cohorts match by age, gender, race and CFTR genotype severity. Exclusion Criteria: * No prior solid organ transplantation * No initiation of an investigation drug within 28 days prior to and including Baseline Visit. * No initiation of new chronic therapy (e.g., ibuprofen, azithromycin, inhaled tobramycin, Cayston, CFTR modulator, etc.) within 28 days prior to and including Baseline visit. * No acute use of antibiotics (oral, inhaled or IV) or acute use of systemic corticosteroids for respiratory tract symptoms within 14 days prior to and including Baseline visit. * For the BIA sub-study - Individuals with an implanted pacemaker will be excluded. * No initiation of a drug for weight loss (such as a GLP-1 receptor agonist) or bariatric surgery within 6-months prior to and including the Baseline visit. * Patients with continued rapid change or extreme GI symptoms related to weight loss therapy should be excluded at the discretion of the study investigator.

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Conditions

The condition(s) this trial relates to.

cystic fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cystic fibrosis

Contacts and locations

Locations

  • Baylor University

    Houston, Texas, 77030, United States

  • Boston Children's Hospital and Brigham and Women's CF Center

    Boston, Massachusetts, 02120, United States

  • Emory

    Atlanta, Georgia, 30324, United States

  • John Hopkins University

    Baltimore, Maryland, 21287, United States

  • Massachusetts General Hospital (MGH)

    Boston, Massachusetts, 02114, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • New York Medical College (NYMC)

    Hawthorne, New York, 10532, United States

  • Northwell LIJ Adult Cystic Fibrosis Center

    New Hyde Park, New York, 11040, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Rutgers Health

    New Brunswick, New Jersey, 08901, United States

  • Tulane University

    New Orleans, Louisiana, 70112, United States

  • University Hospitals

    Cleveland, Ohio, 44106, United States

  • University of Arizona

    Tucson, Arizona, 85724, United States

  • University of Arkansas for Medical Sciences (UAMS)

    Little Rock, Arkansas, 72205, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45220, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Kentucky

    Lexington, Kentucky, 40508, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Oklahoma Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15224, United States

  • University of Virginia Cystic Fibrosis Center

    Charlottesville, Virginia, 22908, United States

  • Washington University School of Medicine (St. Louis)

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.