NCT07464392

Brief Summary

The goal of this clinical trial is to learn whether fecal microbiota transplantation (FMT) works to prevent infections complications in patients in the late phase of moderately severe or severe acute pancreatitis.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Apr 2026

Geographic Reach
1 country

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Apr 2026Sep 2027

First Submitted

Initial submission to the registry

March 1, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

April 2, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

March 1, 2026

Last Update Submit

April 10, 2026

Conditions

Acute Pancreatitis

Keywords

Acute PancreatitisModerately Severe Acute PancreatitisSevere Acute PancreatitisFecal Microbiota TransplantationDigestive System DiseasesPancreatic Diseases

Outcome Measures

Primary Outcomes (1)

  • Incidence of Infectious Complications

    Proportion of participants developing any of the following infectious complications: Infected pancreatic necrosis Bacteremia Pneumonia Urosepsis Infected ascites All infections are weighted equally; multiple infections in the same patient are counted as a single endpoint.

    Within 30 days after enrollment

Secondary Outcomes (20)

  • Incidence of Infectious Complications

    Within 90 days after enrollment

  • Organ Failure

    From enrollment to hospital discharge (up to 90 days)

  • Enteral Nutrition Caloric Intake

    From enrollment to hospital discharge (up to 90 days)

  • NUTRIC Score

    From enrollment to hospital discharge (up to 90 days)

  • Subjective Global Assessment (SGA)

    Baseline, Day 30, Day 60, Day 90

  • +15 more secondary outcomes

Other Outcomes (7)

  • Hospital Total Costs

    From enrollment to hospital discharge (up to 90 days)

  • Serum Cytokine Levels

    From enrollment to hospital discharge (up to 90 days)

  • Serum C-Reactive Protein (CRP) Level

    From enrollment to hospital discharge (up to 90 days)

  • +4 more other outcomes

Study Arms (2)

Fecal Microbiota Transplantation

EXPERIMENTAL

Fecal microbiota transplantation (FMT) liquid, 100 mL , administered via nasojejunal tube, once daily for 5 consecutive days, plus standard treatment.

Biological: Fecal Microbiota Transplantation

Placebo

PLACEBO COMPARATOR

Sterile saline (0.9% sodium chloride) solution, 100 mL, administered via nasojejunal tube, once daily for 5 consecutive days, plus standard treatment. Placebo is identical in appearance to FMT to maintain blinding.

Other: Placebo

Interventions

Fecal Microbiota TransplantationBIOLOGICAL

Fecal microbiota transplantation (FMT) liquid is a biological intervention consisting of processed and standardized human fecal microbiota from healthy donors, suspended in sterile saline with cryoprotectant.

Fecal Microbiota Transplantation
PlaceboOTHER

Sterile saline (0.9% sodium chloride) solution, packaged identically to FMT liquid with opaque materials to maintain blinding, contains no active components and serves as a placebo control.

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 75 years
  • Diagnosed with moderately severe acute pancreatitis (MSAP) or severe acute pancreatitis (SAP) according to the Revised Atlanta Classification 2012, with CT severity index (CTSI) score \> 4
  • Disease duration of 15 to 21 days
  • Already have a nasojejunal tube in place
  • No absolute contraindications to fecal microbiota transplantation
  • Voluntarily sign the written informed consent form

You may not qualify if:

  • Concurrent severe systemic infection
  • Concurrent extra-intestinal organ infection requiring intervention with broad-spectrum antibiotics
  • Intestinal obstruction, active gastrointestinal bleeding, intestinal perforation, fulminant colitis, or toxic megacolon
  • Unable to tolerate enteral nutrition meeting 50% of caloric requirements due to severe diarrhea, significant fibrotic intestinal stricture, severe gastrointestinal bleeding, or high-output intestinal fistula
  • Pre-existing chronic organ dysfunction (heart, lung, liver, kidney, or hematologic system) prior to admission
  • Multiple organ dysfunction syndrome (MODS) with a confirmed duration exceeding 2 weeks
  • Active malignancy
  • Autoimmune disease or immunocompromised status (including solid organ or bone marrow transplantation, AIDS, long-term use of immunosuppressants or hormones)
  • Congenital or acquired immunodeficiency
  • Pregnancy or breastfeeding
  • Severe mental disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

The Second Affiliated Hospital of Fujian University of Traditional Chinese Medicine

Fuzhou, Fujian, China

NOT YET RECRUITING

Quanzhou First Hospital, Fujian

Quanzhou, Fujian, China

NOT YET RECRUITING

Guangdong Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China

NOT YET RECRUITING

Guangzhou Medical University Affiliated Panyu Central Hospital

Guangzhou, Guangdong, China

NOT YET RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

NOT YET RECRUITING

The Affiliated Qingyuan People's Hospital of Guangzhou Medical University

Qingyuan, Guangdong, China

NOT YET RECRUITING

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China

NOT YET RECRUITING

Changhai Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Shanghai Tenth People's Hospital ,Tenth People's Hospital Affiliated to Tongji University)

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

MeSH Terms

Conditions

PancreatitisDigestive System DiseasesPancreatic Diseases

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Yiqi Du, MD

    The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital)

    STUDY CHAIR

  • Xiangyu Kong, MD

    The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiang yu Kong, MD

CONTACT

13564644397xiangyukong185@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 1, 2026

First Posted

March 11, 2026

Study Start

April 2, 2026

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

April 14, 2026

Record last verified: 2026-04

Locations

CN(12)