Breath Test-Based Assessment of SIBO in Chronic Pancreatitis and Partial Pancreatectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: SIBO, Pancreatic Insufficiency, Chronic Pancreatitis, Pancreatic Surgey. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prevalence of SIBO in Patients With Chronic Pancreatitis and After Partial Pancreatectomy: Assessment by Glucose, Lactulose and Mixed Triglyceride Breath Tests.
Overview
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.
Primary outcome measures
- Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) [Time frame: Baseline]
Secondary outcome measures (3)
- Improvement of Gastrointestinal Symptoms After Antibiotic Treatment [Time frame: Up to 3 months after treatment]
- Identification of Alternative Causes of Persistent Symptoms [Time frame: Baseline to 3 months]
- Comparison of Demographic, Clinical, and Laboratory Variables Between Patient Groups [Time frame: Baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Fondazione Policlinico Universitario A. Gemelli IRCCS — Rome
Identifiers
NCT: NCT07479238 · 23363