Gut bacteria may tame pancreatitis — probiotic combo put to the test
NCT ID NCT07720232
First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time
Summary
This trial tests whether adding a specific probiotic (Bacillus subtilis and Enterococcus faecium) to standard lipid-lowering therapy can reduce triglyceride levels and inflammation in people hospitalized with pancreatitis caused by very high triglycerides. About 180 adults with mild to moderate disease will receive either standard care alone or standard care plus the probiotic for 28 days. Researchers will measure blood fats, inflammatory markers, and clinical outcomes like hospital stay length and symptom relief.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a probiotic combination of Bacillus subtilis and Enterococcus faecium (enteric-coated capsules, also known as Meichangan)
- What this could lead to
- If it works, this could offer a simple, safe add-on treatment to lower triglycerides and reduce inflammation in people with pancreatitis caused by high blood fats.
- What could go wrong
- This is a single-center, open-label trial, so results may be influenced by bias. The probiotic may not significantly improve outcomes over standard care, and individual responses could vary.
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.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Feb 2029
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.
- Ages
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18 to 65 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: 1. Meet at least two of the three characteristic criteria for AP:① Acute onset of persistent upper abdominal pain;② Serum amylase and/or lipase activity at least three times above the upper limit of normal;③ Imaging findings on CT, MRI, or abdominal ultrasonography. 2. Meet the diagnostic criteria for hypertriglyceridemia-associated acute pancreatitis (HTG-AP): fulfill the AP diagnostic criteria and concurrent hypertriglyceridemia (serum triglycerides ≥11.3 mmol/L or 5.65-11.3 mmol/L with lactescent serum), with exclusion of other common causes of AP such as cholelithiasis and alcoholism. 3. Admission within 72 hours of symptom onset. 4. Disease severity assessed as mild acute pancreatitis (MAP) within 48 hours of admission, defined by absence of organ dysfunction and absence of local or systemic complications. 5. Age between 18 and 65 years. 6. No history of allergy to microbiological agents. 7. Signed informed consent obtained. Exclusion Criteria: 1. Concurrent biliary, alcoholic, or other etiologies of acute pancreatitis; 2. Acute exacerbation of chronic pancreatitis or pancreatic tumor; 3. Severe hypertriglyceridemia-associated acute pancreatitis, defined as: ① patients classified as moderately severe or severe AP according to the Expert Consensus on the Diagnosis and Treatment of Hypertriglyceridemic Acute Pancreatitis; ② within 48 hours, meeting any one of the following criteria: modified Marshall score ≥2, MCTSI score ≥4, APACHE II score ≥15, BISAP score ≥3, or Ranson score ≥3; patients meeting any of these criteria are excluded; 4. Severe hepatic or renal dysfunction (serum creatinine \>177 μmol/L or ALT \>150 U/L); 5. Active infection, malignancy, immunodeficiency, or requiring long-term use of immunosuppressants; 6. Diagnosed diabetes mellitus; 7. Pregnancy or breastfeeding; 8. History of lactose intolerance; 9. Use within 4 weeks prior to enrollment of antibiotics, probiotics, prebiotics, synbiotics, or other microbiological agents, as well as gastrointestinal motility drugs (e.g., domperidone, mosapride) or other medications that may significantly affect gut microbiota or gastrointestinal function.
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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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Department of Gastroenterology, Zhongshan Hospital, Xiamen University
RECRUITINGXiamen, Fujian, 361004, China
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