Cystic Fibrosis Clinical Trial
Official title:
Phase II Study: LYM-X-SORB™, an Organized Lipid Matrix: Fatty Acids and Choline in CF
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).
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).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
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