Fecal Microbiota Transplantation (FMT) in Patients With Moderate to Severe Acute Pancreatitis
NCT ID: NCT07153809
Last Updated: 2025-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2024-10-12
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Physiological saline placebo will be injected through a nasojejunal nutrition tube once a day for five days.
Placebo
Physiological saline placebo will be injected through a nasojejunal nutrition tube once a day for five days.
FMT
FMT bacterial solution will be injected through a nasojejunal nutrition tube once a day for five days.
After intestinal preparation (via nasal feeding of inulin or oligofructose 24 hours before FMT), the subjects underwent 5-6 consecutive FMT treatments (injecting 100ml of standard bacterial solution 1/d into the nasojejunal nutrition tube, with a minimum of 2.5 \* 1012 CFU of viable cells per 50mL of bacterial solution).
FMT intervention can be performed when the subject's intestinal function is restored and SIRS indicators are significantly relieved compared to before.
During the research period, long-term use of probiotics, antibiotics, and other foods and drugs that interfere with and damage gut microbiota is prohibited. Subjects need to be informed in advance before taking any medication.
All subjects need to complete relevant examinations before enrollment. Conduct a comprehensive safety and efficacy evaluation during treatment, after treatment, and one week after treatment.
FMT
FMT bacterial solution will be injected through a nasojejunal nutrition tube once a day for five days.
Interventions
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FMT
FMT bacterial solution will be injected through a nasojejunal nutrition tube once a day for five days.
Placebo
Physiological saline placebo will be injected through a nasojejunal nutrition tube once a day for five days.
Eligibility Criteria
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Inclusion Criteria
* Organ function: There may be organ failure and systemic complications that can be recovered within 48 hours
* Stage of the disease: Approximately 2 weeks after onset (non acute phase), accompanied by accumulation of pancreatic fluid volume, and significant improvement in CTSI score compared to before (grade II)
* Nutritional support: Enteral nutrition tube has been left in place Feasibility of transplantation: No absolute contraindications for gut microbiota transplantation
* Informed Consent: Voluntarily sign a written informed consent form
* Gastrointestinal status:
Abdominal pressure (bladder pressure measurement)\<12mmHg ◦ Existence of spontaneous defecation/exhaust Significant improvement in abdominal distension compared to before
Exclusion Criteria
* Special population: Pregnant or lactating women
* Informed refusal: Failure to sign informed consent form
* Basic organ dysfunction: Prior to admission, there were chronic organ dysfunction in the heart, lungs, liver, kidneys, or blood system Malignant tumor: Suffering from incurable malignant tumors
* Immune abnormalities:
Autoimmune diseases
◦ Immunosuppression status (solid organ/bone marrow transplantation history, AIDS, long-term use of immunosuppressants/hormones)
* Enteral nutrition intolerance: unable to meet 50% of calorie requirements due to severe diarrhea, fibrotic intestinal stenosis, severe gastrointestinal edema, high flow intestinal fistula, etc
* Systemic infection: meets the diagnostic criteria for systemic inflammatory response syndrome (SIRS)
* Antibiotic dependence: broad-spectrum antibiotic intervention is required for combined extraintestinal organ infections
* Immunodeficiency: Congenital or acquired immunodeficiency
* Mental illness: severe mental disorders
18 Years
70 Years
ALL
No
Sponsors
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Changhai Hospital
OTHER
Responsible Party
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Xiangyu Kong
Principle Investigator
Locations
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Changhai Hospital
Shanghai, Shanghai Municipality, China
Changhai Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHEC2024-297
Identifier Type: -
Identifier Source: org_study_id
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