Breath Test-Based Assessment of SIBO in Chronic Pancreatitis and Partial Pancreatectomy (DCP-PCT-EPI)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pancreatitis; Pancreatic Insufficiency; SIBO; Pancreatic Surgey

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Enrico Celestino Nista; Phone Number: +39 3298973569; Email: enricocelestino.nista@policlinicogemelli.it
• Study Contact Backup: Name: Sara Sofia De Lucia; Phone Number: +39 3391864962

Study Locations

• Italy
  • Rome, Italy, 00168
    • Fondazione Policlinico Universitario A. Gemelli IRCCS
    • Contact: Enrico Celestino Nista; Phone Number: +39 3298973569; Email: enricocelestino.nista@policlinicogemelli.it
    • Contact: Sara Sofia De Lucia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

Inclusion Criteria:

• 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)
• Patients with ampullary or pancreatic tumors who underwent partial pancreatectomy and subsequently developed pancreatic exocrine insufficiency with persistent gastrointestinal symptoms
• Indication to undergo glucose, lactulose, and mixed triglyceride breath tests as part of routine clinical practice
• Signed written informed consent

Exclusion Criteria:

• 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)
• History of major gastrointestinal surgery, including total pancreatectomy
• Presence of other active organic gastrointestinal diseases
• Diabetic gastroparesis
• Known celiac disease
• Obstructive jaundice
• Liver cirrhosis Child-Pugh class C
• Recent or ongoing infections
• Severe chronic obstructive pulmonary disease (COPD)
• Symptomatic thyroid disorders
• Use of antibiotics, laxatives, probiotics, or prokinetic agents within 4 weeks prior to breath testing
• Inability or refusal to undergo study procedures
• Inability or refusal to provide informed consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO)	Assessment of the prevalence of SIBO among two patient groups: individuals with chronic pancreatitis and pancreatic exocrine insufficiency (PEI), and; 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.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 3 months after treatment
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.	Baseline to 3 months
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.	Baseline

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Enrico Celestino Nista, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 26, 2028

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: enzyme replacement therapy; Chronic pancreatitis; Small intestinal bacterial overgrowth; Pancreatic exocrine insufficiency
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Digestive System Diseases; Pancreatic Diseases; Pathological Conditions, Signs and Symptoms; Pancreatitis; Pancreatitis, Chronic; Exocrine Pancreatic Insufficiency
• Other Study ID Numbers: 23363

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No