Protocol of the PANEM trial: A randomized, phase III, parallel-arm, placebo-controlled, double-blind, multi-center superiority trial comparing PANcreatic EnzyMes versus placebo in adults after gastrectomy

Background

Patients after partial or total gastrectomy suffer from malnourishment and diminished quality of life (QOL). Due to altered physiological processes after gastric surgery, coordination between chyme and digestive enzymes produced by the pancreas is affected in many ways, finally leading to maldigestion and malabsorption. These in turn promote various symptoms such as discomfort or steatorrhea. Supplementation of digestive enzymes during food intake may improve digestion and decrease nutrition-related abdominal symptoms, finally leading to higher QOL. To date, trials examining the role of digestive enzyme supplementation in patients with gastrectomy are lacking.