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

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ID
NCT07479238
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
Apr 26, 2028

Study Design

Enrollment
100 participants (estimated)

Primary Outcome Measure

Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) [ Time Frame: Baseline ]

Central Contacts

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