Hidden gut infection may explain why some pancreas patients stay sick
NCT ID NCT07479238
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study will check 100 adults with chronic pancreatitis or who had part of their pancreas removed. Even though they take enzyme pills, they still have stomach pain, bloating, or diarrhea. Researchers will use breath tests to see if a condition called SIBO (too much bacteria in the small intestine) is the hidden cause. If SIBO is found, patients will get antibiotics to see if symptoms improve.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If SIBO is found to be a common cause of persistent symptoms, doctors may routinely test for and treat it, improving quality of life for patients with pancreatic insufficiency.
- What could go wrong
- This is an observational study that only measures how common SIBO is. It does not test a new treatment, so any benefit depends on existing antibiotics working for these patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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).
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, 00168, Italy
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