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.
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)
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)
The study population consists of adult patients (≥18 years) with pancreatic exocrine insufficiency (PEI) attending a tertiary referral center. Eligible participants include: 1. patients with chronic pancreatitis and documented PEI, and 2. patients who underwent partial pancreatectomy for ampullary or pancreatic tumors and subsequently developed PEI. All participants present with persistent gastrointestinal symptoms and are undergoing evaluation with glucose, lactulose, and mixed triglyceride breath tests as part of routine clinical practice to investigate pancreatic exocrine function and the presence of small intestinal bacterial overgrowth (SIBO).
Cohort
Prospective
Not listed
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO)
Assessment of the prevalence of SIBO among two patient groups: 1. individuals with chronic pancreatitis and pancreatic exocrine insufficiency (PEI), and 2. patients who underwent partial pancreatectomy and subsequently developed PEI. SIBO will be diagnosed using glucose and lactulose hydrogen breath tests according to international diagnostic criteria.
Improvement of Gastrointestinal Symptoms After Antibiotic Treatment
Evaluation of reduction or resolution of gastrointestinal symptoms (including abdominal bloating, abdominal pain, diarrhea, excessive flatulence) following antibiotic therapy in participants diagnosed with SIBO.
Identification of Alternative Causes of Persistent Symptoms
Investigation of other potential causes of gastrointestinal symptoms in patients with negative breath tests, including undiagnosed celiac disease, sugar malabsorption, and irritable bowel syndrome, using appropriate diagnostic tests.
Comparison of Demographic, Clinical, and Laboratory Variables Between Patient Groups
Comparison of demographic (age, sex, BMI), clinical (disease duration, symptom severity), and laboratory parameters (e.g., inflammatory markers, pancreatic enzyme markers) between: * patients with SIBO, and * patients with a positive mixed triglyceride breath test indicating impaired pancreatic exocrine function.
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