Double-blind, multicenter, randomized, placebo-controlled, parallel-group study to investigate the effect of Creon 25 000 Minimicrospheres on body mass index (BMI) in patients after gastrectomy

INTERVENTION: Trade Name: Creon enterocapsule Pharmaceutical Form: INN or Proposed INN: pancreatinum Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use CONDITION: Patients atleast 18 years old with total or subtotal gastrektomy. PRIMARY OUTCOME: Main Objective: To evaluate the change from baseline to last value in the body mass index (BMI) after 6 months therapy with pancreatic enzyme supplementation (Creon 25 000 Minimicrospheres) versus placebo in patients after gastrectomy. Primary end point(s): Secondary Objective: To investigate the effect of pancreatic enzyme supplementation (Creon 25 000 Minimicrospheres ) on body composition, on stool fat, on the coefficient of fat absorption, stool weight, clinical global impression of disease symptoms quality of life (Qol), clinical symptoms (gastrointestinal) and the data from the diary (stool frquency, stool consistency, abdominal pain, flatulence, appetite). Elastase will be measured to investigate the status of pancreatic exocrine insufficiency. INCLUSION CRITERIA: *Signed informen consent. *Male or female at least 18 years old. *Patients with total or subtotal (Roux‐en‐Y anastomosis) gastrctomy. *Negative pregnancy test during prestudy. *Women with child‐bearing potential must be using a medically acceptable method of birth control throughout the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range