Phase II Study: LYM-X-SORB™, an Organized Lipid Matrix: Fatty Acids and Choline in CF
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 110
- Locations
- 2
- Primary Endpoint
- Improvements in essential fatty acid (EFA) and choline status over a 12-month period.
Study Overview
Brief Summary
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).
Detailed 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 6 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Improvements in essential fatty acid (EFA) and choline status over a 12-month period.
Time Frame: 12-month period
Secondary Outcomes
- Improvements in growth, nutritional, and pulmonary status over an 18-month period.(18-month period)
Investigators
Walter A. Shaw, Ph.D
Principle Investigator
Avanti Polar Lipids, Inc.