About this trial
Pancreatic exocrine insufficiency (PEI) results from reduced pancreatic enzyme secretion, leading to malabsorption, malnutrition, and impaired quality of life. Although pancreatic enzyme replacement therapy (PERT) is the standard treatment, some patients remain symptomatic despite apparently adequate therapy. Possible causes include suboptimal dosing or concomitant conditions such as small intestinal bacterial overgrowth (SIBO). This study aims to determine the prevalence of SIBO in symptomatic PEI patients despite adequate PERT and to identify treatable causes of persistent symptoms using non-invasive diagnostic tests, with the goal of improving nutritional status and quality of life.
Eligibility criteria
Qualifiers
Age ≥ 18 years
Ability and willingness to participate in the study and to comply with study procedures
Diagnosis of chronic pancreatitis with pancreatic exocrine insufficiency (defined as fecal elastase < 200 µg/g of stool)
Ongoing pancreatic enzyme replacement therapy (PERT) with persistent gastrointestinal symptoms (including abdominal pain, dyspepsia, bloating, excessive flatulence, diarrhea, or steatorrhea) or unintentional weight loss ≥ 10% within the previous 6 months despite adequate PERT dosing (≥ 40,000 IU per main meal and half dose for snacks)
Disqualifiers
Age < 18 years or > 75 years
Pancreatic adenocarcinoma or bile duct tumors under active or previous adjuvant therapy
Moderate to severe liver disease
Severe chronic kidney disease (eGFR < 30 mL/min/1.73 m²)
Trial design
Treatments tested in this trial
- Not listed