Breath Test-Based Assessment of SIBO in Chronic Pancreatitis and Partial Pancreatectomy (NCT07479238) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Breath Test-Based Assessment of SIBO in Chronic Pancreatitis and Partial Pancreatectomy
Italy100 participantsStarted 2026-04-30
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO)