NCT07479238

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

Prevalence of SIBO in Patients With Chronic Pancreatitis and After Partial Pancreatectomy: Assessment by Glucose, Lactulose and Mixed Triglyceride Breath Tests.

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Pancreatic exocrine insufficiency (PEI) is defined as a reduction in pancreatic exocrine secretion below the level required for normal digestion of nutrients, leading to malabsorption, malnutrition, reduced quality of life, and increased morbidity. Chronic pancreatitis represents the most common cause of PEI, although the condition may also develop after pancreaticoduodenectomy. Pancreatic enzyme replacement therapy (PERT) with pancrelipase is the standard treatment and is effective in most patients. However, a proportion of individuals continue to experience gastrointestinal symptoms and weight loss despite apparently adequate therapy, possibly due to suboptimal dosing or concomitant conditions such as small intestinal bacterial overgrowth (SIBO). The mixed triglyceride breath test may help evaluate the adequacy of enzyme replacement therapy, while non-invasive breath tests using glucose or lactulose represent practical diagnostic alternatives for SIBO. This study aims to determine the prevalence of SIBO in patients with PEI who remain symptomatic despite adequate PERT and to identify treatable causes of persistent gastrointestinal symptoms and malnutrition through non-invasive diagnostic tests, with the ultimate goal of improving patients' nutritional status and quality of life.

Conditions

• SIBO
• Pancreatic Insufficiency
• Chronic Pancreatitis
• Pancreatic Surgey

Timeline

• Start date: 2026-04-30
• Primary completion: 2027-04-30
• Completion: 2028-04-26
• First posted: 2026-03-18
• Last updated: 2026-04-13

Locations

1 site across 1 country: Italy