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Acute PancreatitisNCT07464392

FMT for the Prevention of Infectious Complications in Patients With Moderately Severe and Severe Acute Pancreatitis

A study testing Fecal Microbiota Transplantation in people with Acute Pancreatitis, run by Changhai Hospital at 12 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Acute Pancreatitis
What is being tested?
Fecal Microbiota Transplantation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
12 sitesChina
Study dates
2 Apr 2026to 30 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xiang yu Kong, MD contact

13564644397

xiangyukong185@hotmail.com

12 sites in 1 country

China12 sites, 12 recruiting

  • The Second Affiliated Hospital of Fujian University of Traditional Chinese Medicine

    Fuzhou, Fujian

    Xiaoyan Fu, 13859021863

    Not yet recruiting

  • Guangdong Hospital of Traditional Chinese Medicine

    Guangzhou, Guangdong

    Cailing Zhong, 13580565493

    Not yet recruiting

  • Guangzhou Medical University Affiliated Panyu Central Hospital

    Guangzhou, Guangdong

    Yingying Zhao, 15673941051

    Not yet recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

    Peihong Wu, 13926599977

    Not yet recruiting

  • The Affiliated Qingyuan People's Hospital of Guangzhou Medical University

    Qingyuan, Guangdong

    Donglian Liu, 13425262102

    Not yet recruiting

  • Quanzhou First Hospital, Fujian

    Quanzhou, Fujian

    Yisen Huang, 13905983331

    Not yet recruiting

  • Changhai Hospital

    Shanghai, Shanghai Municipality

    Xiangyu Kong, 13564644397, xiangyukong185@hotmail.com

    Recruiting

  • Renji Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality

    Keji Zhang, 13817592023

    Dan Lyu, 13764333620

    Not yet recruiting

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality

    Enqiang Mao, 13501747906

    Not yet recruiting

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality

    Yue Zeng, 18621625166

    Not yet recruiting

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

    Shanghai, Shanghai Municipality

    Feng Liu, 13681973214

    Not yet recruiting

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong

    Shicai Ye, 13360709925

    Not yet recruiting

Other trials in China

About this study

Official title: Fecal Microbiota Transplantation for the Prevention of Infectious Complications in Patients With Moderately Severe and Severe Acute Pancreatitis: A Multicenter, Randomized, Double-Blind Clinical Trial

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.

Read the detailed description

This multicenter, randomized, double-blind, placebo-controlled trial evaluates whether fecal microbiota transplantation (FMT) works to prevent infectious complications in patients in the late phase of moderately severe and severe acute pancreatitis.

Approximately 150 eligible participants will be enrolled across 12 centers in China and randomly assigned to receive either FMT plus standard treatment or placebo plus standard treatment. The intervention is administered via nasojejunal tube once daily for five consecutive days.

The study will assess infection-related outcomes, organ function, nutritional status, gastrointestinal function, gut microbiota changes, need for additional interventions or surgery, mortality, antibiotic use, and healthcare utilization. Exploratory analyses will investigate inflammatory and immune responses, and explore a predictive model based on baseline gut microbiota characteristics and clinical indicators.

All analyses will follow the intention-to-treat principle, aiming to inform better treatment choices and ultimately improve patient outcomes and quality of life.

Being tested
Fecal Microbiota Transplantation, Placebo
Keywords
Acute Pancreatitis, Moderately Severe Acute Pancreatitis, Severe Acute Pancreatitis, Fecal Microbiota Transplantation, Digestive System Diseases, Pancreatic Diseases
Medical subject headings
Pancreatitis, Digestive System Diseases, Pancreatic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT07464392
Study groupRoleWhat they receive
Fecal Microbiota TransplantationExperimentalFecal microbiota transplantation (FMT) liquid, 100 mL , administered via nasojejunal tube, once daily for 5 consecutive days, plus standard treatment.
Receives: Biological: Fecal Microbiota Transplantation
PlaceboPlacebo comparatorSterile 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.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within 30 days after enrollment

Secondary outcomes (20)

  1. Incidence of Infectious Complications

    Proportion of participants developing any infectious complications (as defined in the primary outcome)

    Measured: Within 90 days after enrollment

  2. Organ Failure

    Incidence of organ failure assessed by Sequential Organ Failure Assessment (SOFA) score and modified Marshall score.

    Measured: From enrollment to hospital discharge (up to 90 days)

  3. Enteral Nutrition Caloric Intake

    Daily enteral nutrition caloric intake assessed to evaluate adequacy of nutritional support. Reported in kcal/kg/day.

    Measured: From enrollment to hospital discharge (up to 90 days)

  4. NUTRIC Score

    Nutrition Risk in Critically Ill (NUTRIC) score used to assess nutritional risk in ICU patients. Scores range from 0 to 10; higher scores indicate greater nutritional risk.

    Measured: From enrollment to hospital discharge (up to 90 days)

  5. Subjective Global Assessment (SGA)

    Nutritional status assessed by Subjective Global Assessment. Patients are classified as: A (well-nourished), B (moderately malnourished), or C (severely malnourished).

    Measured: Baseline, Day 30, Day 60, Day 90

  6. Serum Nutritional Protein Markers

    Serum levels of hemoglobin, albumin, and total protein measured to assess nutritional and metabolic status. Reported in g/L.

    Measured: From enrollment to hospital discharge (up to 90 days)

  7. Serum Prealbumin

    Serum levels of prealbumin measured to assess nutritional and metabolic status. Reported in mg/L.

    Measured: From enrollment to hospital discharge (up to 90 days)

  8. Serum Electrolyte Levels

    Serum levels of phosphorus and magnesium measured to assess electrolyte balance. Reported in mmol/L.

    Measured: From enrollment to hospital discharge (up to 90 days)

  9. Body Mass Index (BMI)

    BMI calculated from measured height (meters) and weight (kilograms) to assess nutritional status. Reported in kg/m².

    Measured: From enrollment to 90-day follow-up

  10. Gastrointestinal Symptom Rating Scale (GSRS)

    Gastrointestinal symptoms assessed using the simplified GSRS. Scores range from 0 to 42; higher scores indicate more severe symptoms.

    Measured: From enrollment to 90-day follow-up

  11. Incidence of Gastrointestinal Adverse Events

    Daily monitoring from randomization to discharge of the following events: vomiting (≥1 episode/day), abdominal distension (assessed by daily abdominal circumference measurement), diarrhea (Bristol type 6-7 and ≥3 times/day), intestinal perforation, and abdominal bleeding. Reported in percentage of participants (%).

    Measured: From enrollment to hospital discharge (up to 90 days)

  12. Serum Total Bile Acids Level

    Serum total bile acids measured to assess enterohepatic circulation and gut microbiota-mediated bile acid metabolism. Reported in μmol/L.

    Measured: From enrollment to hospital discharge (up to 90 days)

  13. Serum Diamine Oxidase (DAO) Level

    Serum diamine oxidase level measured as a biomarker of intestinal mucosal barrier integrity and enterocyte damage. Reported in U/L.

    Measured: From enrollment to hospital discharge (up to 90 days)

  14. Serum Endotoxin Level

    Serum endotoxin level measured to assess intestinal permeability and the degree of bacterial translocation across the gut barrier. Reported in EU/mL.

    Measured: From enrollment to hospital discharge (up to 90 days)

  15. Serum D-Lactate Level

    Serum D-lactate level measured as a biomarker of intestinal mucosal permeability and bacterial overgrowth in the gastrointestinal tract. Reported in μmol/L.

    Measured: From enrollment to hospital discharge (up to 90 days)

  16. Gut Microbiota Changes

    Changes in fecal microbiota composition and diversity assessed by metagenomic sequencing.

    Measured: Baseline, Day 7, Day 30, Day 90

  17. Need for Additional Interventions or Surgery

    Proportion of participants requiring additional invasive interventions after FMT treatment.

    Measured: From treatment initiation to 90-day follow-up

  18. Mortality

    All-cause mortality.

    Measured: From enrollment to 90-day follow-up

  19. Antibiotic Utilization

    Proportion of participants receiving antibiotics and duration of antibiotic use.

    Measured: From hospital admission to 90-day follow-up

  20. Hospital Length of Stay

    Duration of hospitalization (days).

    Measured: From enrollment to hospital discharge (up to 90 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2026
  2. Study start2 Apr 2026
  3. Primary completion30 Jul 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07464392
Sponsor's protocol ID
KTSB20250907011
Status last verified
Apr 2026
First submitted
1 Mar 2026
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Fecal Microbiota Transplantation in people with Acute Pancreatitis, run by Changhai Hospital at 12 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiang yu Kong, MD (13564644397, xiangyukong185@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Infectious Complications (time frame: Within 30 days after enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07464392.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.

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