Intestinal Absorption of Lipids Using a Pancreatic Enzyme-Free Nutritional Supplement in Patients with Cystic Fibrosis: A Randomized, Double-Blind, Crossover Pilot Trial

Abstract

Nutritional supplements for patients with exocrine pancreatic insufficiency (EPI) typically utilize pancreatic enzyme replacement therapy (PERT) which is associated with gastrointestinal side effects. We evaluated serum triglyceride levels in patients with cystic fibrosis following consumption of an enzyme-modified oil oral nutritional supplement (EMO-ONS) versus a standard triacylglycerol-based ONS product (TAG-ONS) used concomitantly with PERT and patient tolerability between the two approaches. Ten subjects with CF and EPI taking PERT were enrolled in a single-center, double-blind, cross-over proof of concept trial. Five subjects randomized to Arm 1 were administered a PERT placebo and EMO-ONS and 5 subjects in Arm 2 were administered TAG-ONS+PERT. After 4 to 14 days, subjects received the opposite ONS. Serum triglyceride levels were measured at baseline and hourly for 6 h. Following the above, subjects were randomly assigned to receive 2 daily servings of EMO-ONS+PERT placebo or TAG-ONS+PERT at home for 7-days, self-reporting gastrointestinal symptoms daily. Mean change in peak serum triglyceride levels were similar for both groups (EMO-ONS = 41.9 ± 46.7 mg/dL vs. TAG-ONS+PERT = 46.4 ± 44.1 mg/L; p = 0.85). There was no difference in mean ratio of the serum triglyceride AUC between the two groups (p = 0.58) or self-reported gastrointestinal tolerance. EMO-based products may provide a PERT-free alternative to traditional ONS products in patients with cystic fibrosis.

Individualized pharmaceutical care for a patient after pancreaticoduodenectomy with trypsin replacement nutritional therapy: A case report

“…Subsequently, the patient, whose condition was relatively stable, was given individualized pancreatic enzyme enteric-soluble capsules orally 3 times daily, and he was transitioned from EN to a food homogenate (low-salt and low-fat diabetes homogenate). [2] The patient had no fever, abdominal pain, abdominal distension, vomiting, or other symptoms. His urine was normal and stool was unformed, with 3 to 5 bowel movements per day.…”

“…In order to speed up the patient's recovery, his intestinal mucosa need to be protected and bacterial community transfer needed to be prevented. [2] Physicians took advice D40 Continue ONS sequential therapy, trypsin preparation replacement therapy, and gradually transition to a treatment regimen of whole protein enteral nutrition powder, with trypsin preparations After ONS, the gastrointestinal function of the patient had gradually recovered. Considering the economy and living ability of the patient, the ONS formula was changed and complementary food was gradually added.…”