Effect of timing of enzyme replacement therapy (Creon®) at meals on fat malabsorption in adult patients with cystic fibrosis - a cross-over trial

INTERVENTION: Trade Name: Creon 10.000, hÃ¥rde enterokapsler Pharmaceutical Form: Capsule, hard INN or Proposed INN: Pankreatin CAS Number: 8049‐47‐6 Other descriptive name: PANCREATIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150‐ Trade Name: Creon 25.000, hÃ¥rde enterokapsler Pharmaceutical Form: Capsule, hard INN or Proposed INN: Pankreatin CAS Number: 8049‐47‐6 Other descriptive name: PANCREATIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300‐ Trade Name: Creon 40.000, hÃ¥rde enterokapsler Pharmaceutical Form: Capsule, hard INN or Proposed INN: Pankreatin CAS Number: 8049‐47‐6 Other descriptive name: PANCREATIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400‐ CONDITION: GI pains and fat malabsorption in cystic fibrosis patients with pancreas insufficiency ; MedDRA version: 20.1 Level: LLT Classification code 10025479 Term: Malabsorption syndrome System Organ Class: 100000004856 Therapeutic area: Diseases [C] ‐ Immune System Diseases [C20] PRIMARY OUTCOME: Main Objective: It is explored whether the timing of intake of; enzyme replacement therapy (Creon®) in; relation to the meal has impact on the effect; on GI pains and fat excretion in cystic fibrosis patients with; fat malabsorption. Primary end point(s): GI pains evaluated by patient using VAS‐score. Secondary Objective: Not applicable. Timepoint(s) of evaluation of this end point: GI pains evaluated by patient using VAS‐score:; Evaluated by patient at baseline and; then compared to evaluation by patient after; each intervention period every fourth week,; in a total intervention period of 12 weeks. SECONDARY OUTCOME: Secondary end point(s): ‐ 24 hour excretion of fat in feces in grams; measured as average of 1 day of collection.; ‐ QoL.; ‐ Feces consistency evaluated by patient; using Bristol scale.; ‐ Abdominal circumference.; ‐ 24 hour dietary interview.; ‐ Weight.; ‐ BMI. Timepoint(s) of evaluation of this end point: ‐ 24 hour excretion of fat in feces in grams; measured as average of 1 day of collection:; After each intervention period, every fourth; week.; ‐ QoL: At baseline and after each; intervention period, every fourth week.; ‐ Feces consistency evaluated by patient: At baseline and after each; intervention period, every fourth week.; ‐ Abdominal circumference: At baseline and after each; intervention period, every fourth week.; ‐ 24 hour dietary interview: At baseline and after each; intervention period, every fourth week.; ‐ Weight: At baseline and after each; intervention period, every fourth week.; ‐ BMI: At baseline and after each; intervention period, every fourth week. INCLUSION CRITERIA: ‐ Outpatient adults of legal age (=18 years) with cystic fibrosis and pancreatic insufficiency and who takes enzyme replacement therapy (Creon®) with every fat containing meal of the day. ‐ The patients must be able to physically attend the planned trial days once a month. 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 29 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1