Breath Test-Based Assessment of SIBO in Chronic Pancreatitis and Partial Pancreatectomy

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

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

Trial groups

No trial groups listed