Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fecal Microbiota Transplantation | Experimental | Fecal microbiota transplantation (FMT) liquid, 100 mL , administered via nasojejunal tube, once daily for 5 consecutive days, plus standard treatment. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Microbiota Transplantation | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Infectious Complications | Proportion of participants developing any infectious complications (as defined in the primary outcome) | Within 90 days after enrollment |
| Organ Failure | Incidence of organ failure assessed by Sequential Organ Failure Assessment (SOFA) score and modified Marshall score. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Total Costs | Total hospitalization costs incurred during the index admission, including costs related to medication, procedures, nursing care, and ICU stay. Reported in CNY (Chinese Yuan). | From enrollment to hospital discharge (up to 90 days) |
| Serum Cytokine Levels |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiang yu Kong, MD | Contact | 13564644397 | xiangyukong185@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| 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) |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Fujian University of Traditional Chinese Medicine | Not yet recruiting | Fuzhou | Fujian | China |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | 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. |
|
| From enrollment to hospital discharge (up to 90 days) |
| Enteral Nutrition Caloric Intake | Daily enteral nutrition caloric intake assessed to evaluate adequacy of nutritional support. Reported in kcal/kg/day. | From enrollment to hospital discharge (up to 90 days) |
| 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. | From enrollment to hospital discharge (up to 90 days) |
| 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). | Baseline, Day 30, Day 60, Day 90 |
| Serum Nutritional Protein Markers | Serum levels of hemoglobin, albumin, and total protein measured to assess nutritional and metabolic status. Reported in g/L. | From enrollment to hospital discharge (up to 90 days) |
| Serum Prealbumin | Serum levels of prealbumin measured to assess nutritional and metabolic status. Reported in mg/L. | From enrollment to hospital discharge (up to 90 days) |
| Serum Electrolyte Levels | Serum levels of phosphorus and magnesium measured to assess electrolyte balance. Reported in mmol/L. | From enrollment to hospital discharge (up to 90 days) |
| Body Mass Index (BMI) | BMI calculated from measured height (meters) and weight (kilograms) to assess nutritional status. Reported in kg/m². | From enrollment to 90-day follow-up |
| Gastrointestinal Symptom Rating Scale (GSRS) | Gastrointestinal symptoms assessed using the simplified GSRS. Scores range from 0 to 42; higher scores indicate more severe symptoms. | From enrollment to 90-day follow-up |
| 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 (%). | From enrollment to hospital discharge (up to 90 days) |
| 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. | From enrollment to hospital discharge (up to 90 days) |
| 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. | From enrollment to hospital discharge (up to 90 days) |
| 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. | From enrollment to hospital discharge (up to 90 days) |
| 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. | From enrollment to hospital discharge (up to 90 days) |
| Gut Microbiota Changes | Changes in fecal microbiota composition and diversity assessed by metagenomic sequencing. | Baseline, Day 7, Day 30, Day 90 |
| Need for Additional Interventions or Surgery | Proportion of participants requiring additional invasive interventions after FMT treatment. | From treatment initiation to 90-day follow-up |
| Mortality | All-cause mortality. | From enrollment to 90-day follow-up |
| Antibiotic Utilization | Proportion of participants receiving antibiotics and duration of antibiotic use. | From hospital admission to 90-day follow-up |
| Hospital Length of Stay | Duration of hospitalization (days). | From enrollment to hospital discharge (up to 90 days) |
Serum levels of IL-6, IL-8, IL-10, and TNF-α measured to assess systemic inflammatory response. Reported in pg/mL. |
| From enrollment to hospital discharge (up to 90 days) |
| Serum C-Reactive Protein (CRP) Level | Serum CRP level measured as a marker of systemic inflammation. Reported in mg/L. | From enrollment to hospital discharge (up to 90 days) |
| Serum Procalcitonin (PCT) Level | Serum PCT level measured as a marker of infection and inflammatory response. Reported in ng/mL. | From enrollment to hospital discharge (up to 90 days) |
| CD4+ and CD8+ T Cell Counts | Peripheral blood CD4+ and CD8+ T lymphocyte counts measured to assess cellular immune function. | From enrollment to hospital discharge (up to 90 days) |
| Immune Cell Indices | Neutrophil CD64 index and CD4+/CD8+ ratio assessed to evaluate immune activation and balance. | From enrollment to hospital discharge (up to 90 days) |
| Predictive Model Performance for Infectious Complications and FMT Response | Predictive performance of a model based on baseline gut microbiota characteristics and clinical parameters to identify patients at high risk for infectious complications and to predict individual response to FMT treatment, evaluated by the area under the receiver operating characteristic curve (AUC-ROC). | From enrollment to 90-day follow-up |
| Quanzhou First Hospital, Fujian | Not yet recruiting | Quanzhou | Fujian | China |
|
| Guangdong Hospital of Traditional Chinese Medicine | Not yet recruiting | Guangzhou | Guangdong | China |
|
| Guangzhou Medical University Affiliated Panyu Central Hospital | Not yet recruiting | Guangzhou | Guangdong | China |
|
| The First Affiliated Hospital of Guangzhou Medical University | Not yet recruiting | Guangzhou | Guangdong | China |
|
| The Affiliated Qingyuan People's Hospital of Guangzhou Medical University | Not yet recruiting | Qingyuan | Guangdong | China |
|
| Affiliated Hospital of Guangdong Medical University | Not yet recruiting | Zhanjiang | Guangdong | China |
|
| Changhai Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
|
| Renji Hospital, Shanghai Jiao Tong University School of Medicine | Not yet recruiting | Shanghai | Shanghai Municipality | China |
|
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Not yet recruiting | Shanghai | Shanghai Municipality | China |
|
| Shanghai General Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | China |
|
| Shanghai Tenth People's Hospital ,Tenth People's Hospital Affiliated to Tongji University) | Not yet recruiting | Shanghai | Shanghai Municipality | China |
|
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
Not provided
Not provided