Pancreatic enzyme replacement therapy (PERT) in children with persistent diarrhea: Avoidance of elemental diet need, accessibility and costs

Background and Objectives: Persistent diarrhea has been proven to cause pancreatic exocrine insufficiency, due to decreased stimulation to the pancreas caused by prolonged mucosal injury. Pancreatic enzyme replacement therapy (PERT) given in conjunction to regular treatment is thought to be beneficial in replacing this pancreatic enzyme deficiency, avoiding the need of elemental diet. This study aims to evaluate the benefit of PERT in chil-dren with persistent diarrhea. Methods and Study Design: This is a randomized, two double-blind parallel group, placebo-controlled clinical trial to evaluate the effects of pancreatic enzyme supplementation in persistent diar-rhea. Children age 6-60 months were recruited from pediatric inpatient and outpatient units of five hospitals in Jakarta. Subjects was randomly assigned to either pancreatic enzyme 8371 USP unit of lipase or placebo, 3 times daily for 1 month, as an adjunctive therapy to standard treatment. Subjects were then reevaluated at 2 weeks and 4 weeks interval after administration of enzyme or placebo. Variables observed were length of diarrhea after the start of intervention, change in serum prealbumin, and change in FE-1 between week 0 and week 4. Results: Pan-creatic enzyme supplementation shortens the length of diarrhea by 7 days in the intervention group compared to placebo (p=0.019). Serum prealbumin and FE-1 shows trend that favors the intervention group, although not sta-tistically significant (p>0.05). Conclusion: PERT is clinically effective in reducing the length of diarrhea, thus minimizing the need, accessibility and costs of an elemental diet.