Cystic Fibrosis
Conditions
Brief summary
Children with cystic fibrosis require increased caloric intake to maintain appropriate growth, an important determinant of long-term outcomes. This study seeks to determine the feasibility of using a novel therapeutic food to promote weight gain and growth in children with cystic fibrosis.
Interventions
DIETARY_SUPPLEMENTCystic Fibrosis Ready to Use Supplemental Food
Specially formulated for use by children with Cystic Fibrosis
Sponsors
Cystic Fibrosis Foundation
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Cystic Fibrosis diagnosed by sweat test or genetic testing. * Exocrine Pancreatic Insufficiency and receiving pancreatic enzyme replacement therapy * BMI or weight for age of less than the 50th percentile
Exclusion criteria
* Cystic fibrosis related diabetes mellitus * Cystic fibrosis related liver disease. * Anaphylactic or other allergy to peanut, cow's milk, oat flour or other RUTF ingredients. * Patients who are status-post lung or liver transplantation * Currently receiving enteral supplemental nutrition through gastrostomy or nasogastric tube.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BMI Z-score | 3 months | Change in BMI Z-score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight Z-score | 3 months | Change in Weight Z-score |
| Body Composition | 3 months | Percent body fat mass and lean mass as measured by air displacement plethysmography |
| Pulmonary Function | 3 months | Change in percent estimated forced expiratory volume at one second (FEV1), and forced vital capacity (FVC) |
| Compliance of taking supplemental food | 3 months | Percent consumed as compared to amount recommended. |
| Quality of Life | 3 months | Cystic Fibrosis Questionnaire-Revised (CFQ-R) |
Countries
United States
Outcome results
None listed