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Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05639556
Recruitment Status : Recruiting
First Posted : December 6, 2022
Last Update Posted : February 13, 2024
Sponsor:
Information provided by (Responsible Party):
Jaeb Center for Health Research

Brief Summary:
The goal of the study is to examine multiple markers of anthropometrics, body composition, sarcopenia and frailty and compare them to dual energy X-ray absorptiometry (DXA) output, which is considered the current clinical gold-standard tool to measure body composition. The result of this study will provide detailed data regarding the nutrition and body composition within this Cystic Fibrosis population and also provide a baseline evaluation for use of these biomarkers in the future studies including evaluation of nutritional intervention. Further, the study will also include psychosocial and other patient-reported outcomes and medical contributors to understand their contributions to the nutritional failure in the adult advanced lung disease population. Finally, the study will evaluate both established and emerging nutritional and body composition parameters and link them to clinical outcomes in adults with CF across the spectrum of pulmonary function.

Condition or disease Intervention/treatment
Cystic Fibrosis Diagnostic Test: BMI and lean mass index from DXA Diagnostic Test: Anthropometric Measurements Diagnostic Test: Hand-grip strength Diagnostic Test: Six-minute walk Test Diagnostic Test: Sit-to-Stand Test Diagnostic Test: Short physical performance battery (SPPB) Diagnostic Test: BIA Sub-study Diagnostic Test: Accelerometry to assess physical activity Other: Gastrointestinal (GI) and nutrition questionnaires: Other: Psychosocial questionnaire: PHQ-8 Other: Psychosocial questionnaire: GAD-7 Other: Psychosocial questionnaire: The Treatment Self-Regulation Questionnaire (TSRQ) Other: Psychosocial questionnaire: CF Fatalism Scale Other: Psychosocial questionnaire: Body Esteem Scale for Adolescents and Adults (BESAA) Other: 12-month Questionnaire Other: Oral glucose tolerance testing (OGTT) Device: Continuous glucose monitoring (CGM) Diagnostic Test: Chest CT scans (When available within the past 6 months in medical records) Diagnostic Test: Hologic Dual X-Ray Absorptiometry (DXA) Diagnostic Test: Ultrasound Sub-study of assessment of appendage muscles using ultrasound Diagnostic Test: Psychosocial questionnaire: Hunger Vital Sign questionnaire Other: Respiratory symptom questionnaire: CRISS Diagnostic Test: Spirometry Other: Psychosocial questionnaire: Additional Health Questionnaire

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF
Actual Study Start Date : April 20, 2023
Estimated Primary Completion Date : December 2028
Estimated Study Completion Date : December 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Group/Cohort Intervention/treatment
Cohort 1
Forced expiratory volume in 1 second (FEV1) <60% predicted during the 12 months prior to enrollment (>50% of measurements, eliminating periods of exacerbation). If no stable spirometry data are available in the 12 months prior to enrollment, from the prior 24 months will be used.
Diagnostic Test: BMI and lean mass index from DXA
Estimate and compare correlation between lean mass index from DXA and BMI

Diagnostic Test: Anthropometric Measurements
Skinfold will be assessed with calipers. Circumference will be measured with a tape measure.

Diagnostic Test: Hand-grip strength
A small, handheld dynamometer will be used to measure grip strength, a measure of function, on each hand.

Diagnostic Test: Six-minute walk Test
This will be another functional assessment of fitness. Participants will be asked to walk at their normal pace for 6 minutes.The total distance walked in that time will be measured.

Diagnostic Test: Sit-to-Stand Test
This will be used as a functional assessment of fitness and lower extremity strength. Participants will start seated on a chair and be asked to complete as many sit-to-stand repetitions without using their arms for one minute.

Diagnostic Test: Short physical performance battery (SPPB)
This is an assessment of frailty. The test is completed in approximately 8 minutes. The test consists of 3 assessments: 1) Balance tests where the participant stands and tries to balance with their feet in various positions for 10 seconds each without assistance (side-by-side, heel-to-side, and heel-to-toe); 2) Two 4-meter gait speed tests; and 3) Chair-stand tests (single chair stand, 5 chair stands).

Diagnostic Test: BIA Sub-study
A minimum of 50 individuals will be enrolled. Body composition will be assessed at each study visit using study bioelectrical impendence analysis (BIA).

Diagnostic Test: Accelerometry to assess physical activity
Participants will be provided with a wrist-worn accelerometer/heart rate monitor at the baseline study visit and asked to wear it continuously for at least 3-10 days (two weekdays, one weekend day). Approximately every 3 months, the participant will be asked to again wear the accelerometer. Participants will be able to keep their accelerometers.

Other: Gastrointestinal (GI) and nutrition questionnaires:
Subjects will complete surveys regarding gastrointestinal (GI) symptoms, including the Patient Assessment of Constipation (PAC-SYM) Score, Patient Assessment of Gastrointestinal Symptoms (PACGI-SYM) Score, the Bristol Stool Chart, and the scored Patient-Generated Subjective Global Assessment (PG-SGA).

Other: Psychosocial questionnaire: PHQ-8
This is an 8-item scale that measures depressive symptoms over the past two weeks.

Other: Psychosocial questionnaire: GAD-7
This is a 7-items scale that measures anxiety symptoms over the past two weeks, from not at all to nearly every day.

Other: Psychosocial questionnaire: The Treatment Self-Regulation Questionnaire (TSRQ)
This is a 15-item scale that assesses the degree to which participants' motivation is autonomous or self-regulated.

Other: Psychosocial questionnaire: CF Fatalism Scale
The CF Fatalism Scale measures the belief in a lack of personal power or control over one's future and has 13 items.

Other: Psychosocial questionnaire: Body Esteem Scale for Adolescents and Adults (BESAA)
The Body Esteem Scale for Adolescents and Adults (BESAA) is 23-item measurement of self-evaluations of one's body or appearance.

Other: 12-month Questionnaire
A short questionnaire designed to explore participants' perspectives of the acceptability and feasibility of nutritional assessments used in STRONG-CF will be given to all study participants at the end of the study.

Other: Oral glucose tolerance testing (OGTT)
For subjects without previously diagnosed CFRD, an OGTT will be performed at baseline and 12-months with samples analyzed at the central lab.

Device: Continuous glucose monitoring (CGM)
Subjects will wear a Dexcom G6Pro sensor in blinded mode for three 10-day periods to collect comprehensive glucose data.

Diagnostic Test: Chest CT scans (When available within the past 6 months in medical records)
Standard of Care chest CT images will be drawn from the medical record, as available, from enrolled participants. FEV1 measurements prior to chest CT scans will be recorded to account for possible illness occurring at the time of scanning. Quantitative assessment of the pectoralis muscle area will be performed on the first single axial image above the aortic arch. Any additional standard of care chest CT's that are performed while the participant is enrolled in the study will also be collected and have a quantitative assessment of the pectoralis muscle performed.

Diagnostic Test: Hologic Dual X-Ray Absorptiometry (DXA)
DXA measurements for whole body, total hip and lumbar spine will be acquired using the Hologic DXA and standard positioning as noted in the DXA Manual of Operations. DXA will be used to estimate total and regional body composition, which will include body fat and lean body mass. This will be used as the gold standard from which to validate BIA and MAMC.

Diagnostic Test: Ultrasound Sub-study of assessment of appendage muscles using ultrasound
A minimum of 50 individuals will be enrolled. At each study visit, participants will undergo ultrasound muscle measurements (cross-sectional area and muscle thickness) of the biceps and quadriceps on each (left and right) side of the body (4 total areas). These measurements will be obtained in triplicate for each patient.

Diagnostic Test: Psychosocial questionnaire: Hunger Vital Sign questionnaire
Screening tool for identifying households at risk of food insecurity and poor health outcomes linked to food insecurity with 3-items over the last 12 months.

Other: Respiratory symptom questionnaire: CRISS
Chronic Respiratory Infection Symptom Score (CRISS) is an 8-item respiratory symptom questionnaire covering the last 24-hours.

Diagnostic Test: Spirometry
Spirometry will be performed in accordance with the current American Thoracic Society recommendations for the performance and interpretation of tests.

Other: Psychosocial questionnaire: Additional Health Questionnaire
Single question over the last 3 months/90 days about cannabis use for GI problems and appetite. The clinical sites will not see the responses to this question. It will be completed by the participant online either during the study visit or at home.

Cohort 2
FEV1 ≥60% predicted during the 12 months prior to enrollment (>50% of measurements, eliminating periods of exacerbation).
Diagnostic Test: BMI and lean mass index from DXA
Estimate and compare correlation between lean mass index from DXA and BMI

Diagnostic Test: Anthropometric Measurements
Skinfold will be assessed with calipers. Circumference will be measured with a tape measure.

Diagnostic Test: Hand-grip strength
A small, handheld dynamometer will be used to measure grip strength, a measure of function, on each hand.

Diagnostic Test: Six-minute walk Test
This will be another functional assessment of fitness. Participants will be asked to walk at their normal pace for 6 minutes.The total distance walked in that time will be measured.

Diagnostic Test: Sit-to-Stand Test
This will be used as a functional assessment of fitness and lower extremity strength. Participants will start seated on a chair and be asked to complete as many sit-to-stand repetitions without using their arms for one minute.

Diagnostic Test: Short physical performance battery (SPPB)
This is an assessment of frailty. The test is completed in approximately 8 minutes. The test consists of 3 assessments: 1) Balance tests where the participant stands and tries to balance with their feet in various positions for 10 seconds each without assistance (side-by-side, heel-to-side, and heel-to-toe); 2) Two 4-meter gait speed tests; and 3) Chair-stand tests (single chair stand, 5 chair stands).

Diagnostic Test: BIA Sub-study
A minimum of 50 individuals will be enrolled. Body composition will be assessed at each study visit using study bioelectrical impendence analysis (BIA).

Diagnostic Test: Accelerometry to assess physical activity
Participants will be provided with a wrist-worn accelerometer/heart rate monitor at the baseline study visit and asked to wear it continuously for at least 3-10 days (two weekdays, one weekend day). Approximately every 3 months, the participant will be asked to again wear the accelerometer. Participants will be able to keep their accelerometers.

Other: Gastrointestinal (GI) and nutrition questionnaires:
Subjects will complete surveys regarding gastrointestinal (GI) symptoms, including the Patient Assessment of Constipation (PAC-SYM) Score, Patient Assessment of Gastrointestinal Symptoms (PACGI-SYM) Score, the Bristol Stool Chart, and the scored Patient-Generated Subjective Global Assessment (PG-SGA).

Other: Psychosocial questionnaire: PHQ-8
This is an 8-item scale that measures depressive symptoms over the past two weeks.

Other: Psychosocial questionnaire: GAD-7
This is a 7-items scale that measures anxiety symptoms over the past two weeks, from not at all to nearly every day.

Other: Psychosocial questionnaire: The Treatment Self-Regulation Questionnaire (TSRQ)
This is a 15-item scale that assesses the degree to which participants' motivation is autonomous or self-regulated.

Other: Psychosocial questionnaire: CF Fatalism Scale
The CF Fatalism Scale measures the belief in a lack of personal power or control over one's future and has 13 items.

Other: Psychosocial questionnaire: Body Esteem Scale for Adolescents and Adults (BESAA)
The Body Esteem Scale for Adolescents and Adults (BESAA) is 23-item measurement of self-evaluations of one's body or appearance.

Other: 12-month Questionnaire
A short questionnaire designed to explore participants' perspectives of the acceptability and feasibility of nutritional assessments used in STRONG-CF will be given to all study participants at the end of the study.

Other: Oral glucose tolerance testing (OGTT)
For subjects without previously diagnosed CFRD, an OGTT will be performed at baseline and 12-months with samples analyzed at the central lab.

Device: Continuous glucose monitoring (CGM)
Subjects will wear a Dexcom G6Pro sensor in blinded mode for three 10-day periods to collect comprehensive glucose data.

Diagnostic Test: Chest CT scans (When available within the past 6 months in medical records)
Standard of Care chest CT images will be drawn from the medical record, as available, from enrolled participants. FEV1 measurements prior to chest CT scans will be recorded to account for possible illness occurring at the time of scanning. Quantitative assessment of the pectoralis muscle area will be performed on the first single axial image above the aortic arch. Any additional standard of care chest CT's that are performed while the participant is enrolled in the study will also be collected and have a quantitative assessment of the pectoralis muscle performed.

Diagnostic Test: Hologic Dual X-Ray Absorptiometry (DXA)
DXA measurements for whole body, total hip and lumbar spine will be acquired using the Hologic DXA and standard positioning as noted in the DXA Manual of Operations. DXA will be used to estimate total and regional body composition, which will include body fat and lean body mass. This will be used as the gold standard from which to validate BIA and MAMC.

Diagnostic Test: Ultrasound Sub-study of assessment of appendage muscles using ultrasound
A minimum of 50 individuals will be enrolled. At each study visit, participants will undergo ultrasound muscle measurements (cross-sectional area and muscle thickness) of the biceps and quadriceps on each (left and right) side of the body (4 total areas). These measurements will be obtained in triplicate for each patient.

Diagnostic Test: Psychosocial questionnaire: Hunger Vital Sign questionnaire
Screening tool for identifying households at risk of food insecurity and poor health outcomes linked to food insecurity with 3-items over the last 12 months.

Other: Respiratory symptom questionnaire: CRISS
Chronic Respiratory Infection Symptom Score (CRISS) is an 8-item respiratory symptom questionnaire covering the last 24-hours.

Diagnostic Test: Spirometry
Spirometry will be performed in accordance with the current American Thoracic Society recommendations for the performance and interpretation of tests.

Other: Psychosocial questionnaire: Additional Health Questionnaire
Single question over the last 3 months/90 days about cannabis use for GI problems and appetite. The clinical sites will not see the responses to this question. It will be completed by the participant online either during the study visit or at home.




Primary Outcome Measures :
  1. Correlation between DXA lean mass index and BMI [ Time Frame: Baseline and 1 year ]
    Estimate and compare correlation between lean mass index from DXA (kg/m2) and BMI (kg/m2)

  2. Correlation between DXA lean mass index and mid-arm muscle circumference [ Time Frame: Baseline and 1 year ]
    Estimate and compare correlation between lean mass index from DXA (kg/m2) and mid-arm muscle circumference (cm)

  3. Correlation between DXA lean mass index and hand-grip strength [ Time Frame: Baseline and 1 year ]
    Estimate and compare correlation between lean mass index from DXA (kg/m2) and hand-grip strength (kg)

  4. Correlation between DXA lean mass index and the 6-minute walk distance traveled [ Time Frame: Baseline and 1 year ]
    Estimate and compare correlation between lean mass index from DXA (kg/m2) and 6-minute walk (distance traveled in six minutes)

  5. Correlation between DXA lean mass index and the 1-minute sit-to-stand number of repetitions [ Time Frame: Baseline and 1 year ]
    Estimate and compare correlation between lean mass index from DXA (kg/m2) and 1-minute sit-to-stand (number of sit-to-stand repetitions in one minute)

  6. Correlation between DXA lean mass index and Short Physical Performance Battery frailty score [ Time Frame: Baseline and 1 year ]
    Estimate and compare correlation between lean mass index from DXA (kg/m2) and Short Physical Performance Battery frailty score (total points)


Secondary Outcome Measures :
  1. Characterize lean mass index from DXA cross-sectionally and longitudinally [ Time Frame: Baseline and 1 year ]
    Characterize lean mass index from DXA cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance

  2. Characterize BMI cross-sectionally and longitudinally [ Time Frame: Baseline and 1 year ]
    Characterize lean mass index from BMI cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance

  3. Characterize mid-arm measurement circumference cross-sectionally and longitudinally [ Time Frame: Baseline and 1 year ]
    Characterize lean mass index from mid-arm circumference measurements cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance

  4. Characterize hand-grip strength cross-sectionally and longitudinally [ Time Frame: Baseline and 1 year ]
    Characterize hand-grip strength cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance

  5. Characterize 1 minute sit-to-stand repetitions cross-sectionally and longitudinally [ Time Frame: Baseline and 1 year ]
    Characterize the 1 minute sit-to-stand repetitions cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance

  6. Characterize mid-arm 6-minute walk test distance traveled cross-sectionally and longitudinally [ Time Frame: Baseline and 1 year ]
    Characterize the 6-minute walk test distance traveled cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance

  7. Characterize the Short Physical Performance Battery frailty score cross-sectionally and longitudinally [ Time Frame: Baseline and 1 year ]
    Characterize the Short Physical Performance Battery frailty score cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance

  8. Compare lean mass index from DXA between participants with FEV1 <60% to matched participants with FEV1 ≥60% [ Time Frame: Baseline and 1 year ]
    Compare lean mass index from DXA between participants with FEV1 <60% to matched participants with FEV1 ≥60%.

  9. Compare BMI between participants with FEV1 <60% to matched participants with FEV1 ≥60% [ Time Frame: Baseline and 1 year ]
    Compare BMI between participants with FEV1 <60% to matched participants with FEV1 ≥60%.

  10. Compare lean mass index from mid-arm muscle circumference between participants with FEV1 <60% to matched participants with FEV1 ≥60% [ Time Frame: Baseline and 1 year ]
    Compare lean mass index from mid-arm muscle circumference between participants with FEV1 <60% to matched participants with FEV1 ≥60%.

  11. Compare hand-grip strength between participants with FEV1 <60% to matched participants with FEV1 ≥60% [ Time Frame: Baseline and 1 year ]
    Compare hand-grip strength between participants with FEV1 <60% to matched participants with FEV1 ≥60%.

  12. Compare the 1-minute sit-to-stand repetitions between participants with FEV1 <60% to matched participants with FEV1 ≥60% [ Time Frame: Baseline and 1 year ]
    Compare the 1-minute sit-to-stand repetitions between participants with FEV1 <60% to matched participants with FEV1 ≥60%.

  13. Compare the 6-minute walk test distance between participants with FEV1 <60% to matched participants with FEV1 ≥60% [ Time Frame: Baseline and 1 year ]
    Compare the 6-minute walk test distance between participants with FEV1 <60% to matched participants with FEV1 ≥60%.

  14. Compare the Short Physical Performance Battery frailty score between participants with FEV1 <60% to matched participants with FEV1 ≥60% [ Time Frame: Baseline and 1 year ]
    Compare the Short Physical Performance Battery frailty score between participants with FEV1 <60% to matched participants with FEV1 ≥60%.

  15. Evaluate mean glucose in participants with FEV1 <60% and matched participants with FEV1 ≥60% [ Time Frame: Baseline and 1 year ]
    Evaluate mean glucose from continuous glucose measurement data in participants with FEV1 <60% and matched participants with FEV1 ≥60%

  16. Evaluate % time above 140 mg/dL in participants with FEV1 <60% and matched participants with FEV1 ≥60% [ Time Frame: Baseline and 1 year ]
    Evaluate % time above 140 mg/dL from continuous glucose measurement data in participants with FEV1 <60% and matched participants with FEV1 ≥60%

  17. Evaluate % time above 180 mg/dL in participants with FEV1 <60% and matched participants with FEV1 ≥60% [ Time Frame: Baseline and 1 year ]
    Evaluate % time above 180 mg/dL from continuous glucose measurement data in participants with FEV1 <60% and matched participants with FEV1 ≥60%

  18. Evaluate peak glucose in participants with FEV1 <60% and matched participants with FEV1 ≥60% [ Time Frame: Baseline and 1 year ]
    Evaluate peak glucose from continuous glucose measurement data in participants with FEV1 <60% and matched participants with FEV1 ≥60%

  19. Evaluate % time below 70 mg/dL in participants with FEV1 <60% and matched participants with FEV1 ≥60% [ Time Frame: Baseline and 1 year ]
    Evaluate % time below 70 mg/dL from continuous glucose measurement data in participants with FEV1 <60% and matched participants with FEV1 ≥60%

  20. Evaluate % time below 54 mg/dL in participants with FEV1 <60% and matched participants with FEV1 ≥60% [ Time Frame: Baseline and 1 year ]
    Evaluate % time below 54 mg/dL from continuous glucose measurement data in participants with FEV1 <60% and matched participants with FEV1 ≥60%

  21. Evaluate the standard deviation in CGM glucose data in participants with FEV1 <60% and matched participants with FEV1 ≥60% [ Time Frame: Baseline and 1 year ]
    Evaluate the standard deviation in CGM glucose data in participants with FEV1 <60% and matched participants with FEV1 ≥60%

  22. Evaluate the coefficient of variation in CGM glucose data in participants with FEV1 <60% and matched participants with FEV1 ≥60%participants with FEV1 ≥60% [ Time Frame: Baseline and 1 year ]
    Evaluate the coefficient of variation in CGM glucose data in participants with FEV1 <60% and matched participants with FEV1 ≥60%participants with FEV1 ≥60%


Biospecimen Retention:   Samples Without DNA
Serum, plasma, urine and stool samples will be collected.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • Cohort 1: Patients are eligible if their percentage of predicated forced expiratory volume in1 second (FEV1) is 60% or lower at screening.
  • Cohort 2: Patients are eligible if their percentage of predicted forced expiratory volume in 1 second (FEV1) is 60% or greater at screening.
  • 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 Visit 1
  • No initiation of new chronic therapy (e.g., ibuprofen, azithromycin, inhaled tobramycin, Cayston, CFTR modulator) within 28 days prior to and including Visit 1.
  • 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 Visit 1.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05639556


Contacts
Layout table for location contacts
Contact: Judy Sibayan (813) 975-8690 jsibayan@jaeb.org

Locations
Show Show 23 study locations
Sponsors and Collaborators
Jaeb Center for Health Research
Investigators
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Principal Investigator: Adam Stein Northwestern
Principal Investigator: Jessica Alvarez Emory University
Principal Investigator: Melissa Putman Massachusetts General Hospital
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Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT05639556    
Other Study ID Numbers: STRONG-CF
First Posted: December 6, 2022    Key Record Dates
Last Update Posted: February 13, 2024
Last Verified: February 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cystic Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases