Pancreatic exocrine insufficiency
Conditions
Interventions
Group A: Patients with severe exocrine pancreatic insufficiency (SPEI):One tablet of Tryptic Tablets of Aspergillus oryzae, tid oral
Group B: Patients with severe exocrine pancreatic insufficiency (SPEI):Two tablets of Tryptic Tablets of Aspergillus oryzae, tid oral
Group C: Patients with exocrine pancreatic insufficiency (PEI):One tablet of Tryptic Tablets of Aspergillus oryzae, tid oral
Sponsors
Huadong Hospital
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Part I investigated subjects diagnosed with PEI or SPEI by fecal elastase-1 (FE-1); 2) The patient voluntarily participates in and signs the informed consent form.
Exclusion criteria
Exclusion criteria: Laboratory studies of fecal elastase-1 (FE-1) in the diagnosis of pancreatic exocrine insufficiency (PEI) in subjects with fecal elastase-1 (FE-1) concentrations > 200 µg/g.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dyspepsia Symptom Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life Score;Stool appearance and frequency;Weight;Body Mass Index;Grip strength;Mini-Nutritional Assessment, MNA;Laboratory tests; | — |
Countries
China
Contacts
Public ContactWei Zhang
Outcome results
None listed