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

The Washington University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Cystic Fibrosis

Treatments: Dietary Supplement: Cystic Fibrosis Ready to Use Supplemental Food

Study type: Interventional

Funder types: Other

Identifiers

NCT03462056

201712139

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

CF Ready to Use Supplemental Food.

Experimental group

Description:

Participants will receive Cystic Fibrosis Ready to Use Supplemental Food sufficient to provide approximately 20% of estimated daily caloric needs up to 500kcal of total calories, 18.5 grams of protein and 28g of fat. The supplement is also optimized to provide excellent protein quality and optimal polyunsaturated fatty acid composition

Treatment:

Dietary Supplement: Cystic Fibrosis Ready to Use Supplemental Food