Ready to Use Therapeutic Food (RUTF) to Promote Growth in Cystic Fibrosis

Phase 1

Completed

• Conditions: Cystic Fibrosis

• Registration Number: NCT03462056
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-05
• Study First Submitted QC: 2018-03-05
• Study First Posted: 2018-03-12
• Study Start: 2018-05-17
• Primary Completion: 2019-04-30
• Status Verified: 2019-06
• Study Completion: 2019-06-14
• Last Update Submitted: 2019-06-19
• Last Update Posted: 2019-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
BMI Z-score	3 months	Change in BMI Z-score

Secondary Outcome Measures

Name	Time	Method
Body Composition	3 months	Percent body fat mass and lean mass as estimated by skinfold measurements (triceps and subscapular)
Pulmonary Function	3 months	Change in percent estimated forced expiratory volume at one second (FEV1), and forced vital capacity (FVC)
Weight Z-score	3 months	Change in Weight Z-score
Quality of Life	3 months	Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Compliance of taking supplemental food	3 months	Percent consumed as compared to amount recommended.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States