Study of LYM-X-SORB™ to Improve Fatty Acid and Choline Status in Children With CF and PI

Avanti Polar Lipids

Status and phase

Completed

Phase 2

Conditions

Pancreatic Insufficiency

Cystic Fibrosis

Treatments

Dietary Supplement: Lym-X-Sorb powder

Dietary Supplement: Placebo powder

Study type

Interventional

Funder types

Industry

NIH

Identifiers

NCT00406536

R44DK060302 (U.S. NIH Grant/Contract)

DK60302

2R44DK060302-02A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this phase II research study is to evaluate the effectiveness of the next generation LYM-X-SORB™ in improving the essential fatty acid (EFA) and choline status for children and adolescents with Cystic Fibrosis (CF) and pancreatic insufficiency (PI).

Full description

Fat malabsorption is common in individuals with cystic fibrosis (CF) and pancreatic insufficiency (PI). This places them at risk for caloric, essential fatty acid, and choline deficiency, which may in turn, lead to growth failure and a poorer clinical course. The purpose of this research study is to find whether or not taking LYM-X-SORB™ over an 18-month period, every day, will correct the problem people with CF and PI have with absorbing fat and choline. Participation will help CF doctors and other healthcare professionals learn more about the potential benefits of LYM-X-SORB™ to children and adolescents with CF and PI. These benefits may include better absorption of fat, better choline status, better growth in height, weight, muscle and bone, better lungs, and improvement of health status.

The study will enroll a total of 78 participants from Children's Hospital of Philadelphia (CHOP) and from several other Cystic Fibrosis Centers. One half of the participants will be randomly picked to receive the active powder with the LYM-X-SORB™ supplement and one half will receive a placebo (with no active supplement).

Enrollment

110 patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosed as having cystic fibrosis (CF) with pancreatic insufficiency (PI)
Subjects aged 6 to 17 years of age
In usual state of good health
Family and subject commitment to the 18-month study protocol
Fecal elastase < 15µg/g stool

Exclusion criteria

Forced expiratory volume at one second, % predicted (FEV1) < 40% predicted
Other chronic health conditions that may affect GI absorption, growth, dietary intake, nutritional status
Liver disease, lung transplant, celiac disease, allergy/intolerance to wheat/gluten, pregnant
Participation in another CF nutrition-related intervention study
Regular intake of fatty acids (i.e., fish oils) or choline nutritional supplements
Home parenteral lipid administration (i.e., intralipids)