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

NCT07479238 | Not Yet Recruiting DMC

• 1 other identifier: 23363
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SIBO; Chronic Pancreatitis; Pancreatic Insufficiency; Pancreatic Surgey

Keywords

Pancreatic exocrine insufficiency; Chronic pancreatitis; enzyme replacement therapy; Small intestinal bacterial overgrowth

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Secondary Outcomes (3)

• Improvement of Gastrointestinal Symptoms After Antibiotic Treatment

  Up to 3 months after treatment

• Identification of Alternative Causes of Persistent Symptoms

  Baseline to 3 months

• Comparison of Demographic, Clinical, and Laboratory Variables Between Patient Groups

  Baseline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency; Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Pancreatitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Enrico Celestino Nista

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enrico Celestino Nista

CONTACT

+39 3298973569; enricocelestino.nista@policlinicogemelli.it

Sara Sofia De Lucia

CONTACT

+39 3391864962

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 18, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 26, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)