Fecal Microbiota Transplantation (FMT) in Patients With Moderate to Severe Acute Pancreatitis

NCT07153809 | Recruiting

• 1 other identifier: CHEC2024-297
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a randomized, double-blind and placebo-controlled study. The purpose of this study is to evaluate the efficacy and safety of FMT in patients with moderate to severe acute pancreatitis.

Conditions

Acute Pancreatitis; Severe Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

• Pancreatic infectious complications

  Infectious pancreatic necrosis, sepsis, and pancreatic fistula. Infectious pancreatic necrosis: (1) Imaging suggests the formation of gas at the site of necrosis aggregation; (2) Gram staining or culture positivity of necrotic specimens obtained through percutaneous fine needle aspiration (FNAC); (3) Clinically suspected infection symptoms. However, due to the high false positive rate, routine FNAC examination is not recommended. Sepsis: (1) Two blood cultures (or bone marrow cultures) are positive for the same pathogen. (2) Systemic inflammatory response syndrome (SIRS) occurs. Pancreatic fistula: (1) History of acute necrotizing pancreatitis attacks; (2) Imaging supports the diagnosis of pancreatic fistula. Measurement: Yes/No (incidence rate)

  through study completion, an average of 1 year

Secondary Outcomes (7)

• Change in CTSI score

  through study completion, an average of 1 year

• Changes in gut microbiome community

  Up to 1 week

• Gastrointestinal mucosal barrier index

  Up to 1 weeks

• Markers of inflammatory conditions

  Up to 3 months

• Inflammatory markers

  Up to 3 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Physiological saline placebo will be injected through a nasojejunal nutrition tube once a day for five days.

Procedure: Placebo

FMT

EXPERIMENTAL

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.

Procedure: FMT

Interventions

FMT PROCEDURE

FMT bacterial solution will be injected through a nasojejunal nutrition tube once a day for five days.

FMT

Placebo PROCEDURE

Physiological saline placebo will be injected through a nasojejunal nutrition tube once a day for five days.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-70 years old Diagnosis: Meets the diagnostic criteria for severe acute pancreatitis (SAP)
• 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

You may not qualify if:

• Serious complications: combined gastrointestinal bleeding or intestinal fistula
• 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

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (2)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Central Study Contacts

Kong Xiang yu, associate professor

CONTACT

13564644397; xiangyukong185@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 7, 2024
• First Posted: September 4, 2025
• Study Start: October 12, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

CN (2)