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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-17

Study Completion Date

2019-06-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CF Ready to Use Supplemental Food.

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

Group Type EXPERIMENTAL

Cystic Fibrosis Ready to Use Supplemental Food

Intervention Type DIETARY_SUPPLEMENT

Specially formulated for use by children with Cystic Fibrosis

Interventions

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Cystic Fibrosis Ready to Use Supplemental Food

Specially formulated for use by children with Cystic Fibrosis

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No