Acute PancreatitisNCT07153809
Fecal Microbiota Transplantation (FMT) in Patients With Moderate to Severe Acute Pancreatitis
A study testing FMT in people with Acute Pancreatitis and Severe Acute Pancreatitis, run by Changhai Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Pancreatitis, Severe Acute Pancreatitis
- What is being tested?
- FMT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesChina
- Study dates
- 12 Oct 2024to 31 Dec 2026
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Kong Xiang yu, Associate Professor, 13564644397, xiangyukong185@hotmail.com
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Xiangyu Kong, 13564644397, xiangyukong185@hotmail.com
About this study
Official title: Randomized, Double-blind Clinical Trial on the Efficacy and Safety of Gut Microbiota Transplantation (FMT) in the Treatment of Moderate to Severe Acute Pancreatitis
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.
Read the detailed description
This study is a single center, randomized controlled trial. After the start of the study, 80 patients with acute moderate to severe acute pancreatitis were randomly selected according to inclusion and exclusion criteria and divided into an intervention group (n=40) and a control group (n=40) to explore the safety and efficacy of FMT in preventing late complications of acute moderate to severe acute pancreatitis.
- Conditions
- Acute Pancreatitis, Severe Acute Pancreatitis
- Being tested
- FMT, Placebo
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMTProcedure or surgery
FMT bacterial solution will be injected through a nasojejunal nutrition tube once a day for five days.
PlaceboProcedure or surgery
Physiological saline placebo will be injected through a nasojejunal nutrition tube once a day for five days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Physiological saline placebo will be injected through a nasojejunal nutrition tube once a day for five days. Receives: 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. Receives: Procedure: FMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: through study completion, an average of 1 year
Secondary outcomes (7)
Change in CTSI score
The CT Severity Score (CTSI) of acute pancreatitis can evaluate the severity of acute pancreatitis, predict the probability of complications such as organ failure in the early stages of the disease, and assess the prognosis of patients
Method:
Measure CTSI scores during baseline and after FMT treatment
Measured: through study completion, an average of 1 year
Changes in gut microbiome community
The average change in bacterial species relative to baseline compared to one week after fecal microbiota transplantation (FMT).
Measured: Up to 1 week
Gastrointestinal mucosal barrier index
Diamine oxidase (DAO): It is a marker enzyme of intestinal mucosal cells. D-Lactic acid: It is a metabolic product of intestinal bacteria. Under normal circumstances, the content in plasma is extremely low. When the intestinal mucosa is damaged, DAO and D-lactate will be released into the blood in large quantities, leading to a significant increase in blood concentration, which is an important indicator for evaluating the structural integrity of the intestinal mucosa. During the treatment process, changes in DAO and D-lactate levels can reflect the progress of intestinal mucosal repair.
DAO decline rate Formula: (Baseline Value -7-Day Value)/Baseline Value x 100% Unit:% D-lactic acid decline rate Formula: (Baseline Value -7-Day Value)/Baseline Value x 100% Unit:%
Measured: Up to 1 weeks
Markers of inflammatory conditions
C-reactive protein (CRP) is a measure of inflammatory status and is considered a biomarker of inflammation in patients with pancreatitis.
Measured: Up to 3 months
Inflammatory markers
Procalcitonin (PCT) is a measure of inflammatory status and is considered a biomarker of inflammation in patients with pancreatitis
Measured: Up to 3 months
Inflammatory markers
Interleukin-6 (IL-6) is a measure of inflammatory status and is considered a biomarker of inflammation in patients with pancreatitis
Measured: Up to 3 months
Inflammatory markers
lactic acid is a measure of inflammatory status and is considered a biomarker of inflammation in patients with pancreatitis
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start12 Oct 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangyu Kong, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153809
- Sponsor's protocol ID
- CHEC2024-297
- Status last verified
- Aug 2025
- First submitted
- 7 Sep 2024
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind Clinical Trial on the Efficacy and Safety of Gut Microbiota Transplantation (FMT) in the Treatment of Moderate to Severe Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT07153809
- Acronym / sponsor ID
- CHEC2024-297
- Conditions
- Acute Pancreatitis, Severe Acute Pancreatitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 12 Oct 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a single center, randomized controlled trial. After the start of the study, 80 patients with acute moderate to severe acute pancreatitis were randomly selected according to inclusion and exclusion criteria and divided into an intervention group (n=40) and a control group (n=40) to explore the safety and efficacy of FMT in preventing late complications of acute moderate to severe acute pancreatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Procedure: PlaceboPhysiological saline placebo will be injected through a nasojejunal nutrition tube once a day for five days. |
| FMT | Experimental | Procedure: FMTFMT 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FMTFMT bacterial solution will be injected through a nasojejunal nutrition tube once a day for five days. | Procedure or surgery | FMT |
| PlaceboPhysiological saline placebo will be injected through a nasojejunal nutrition tube once a day for five days. | Procedure or surgery | Placebo |
Primary outcome
Pancreatic infectious complications
Time frame: through study completion, an average of 1 year
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)
7 secondary outcomes
Change in CTSI score
Time frame: through study completion, an average of 1 year
Changes in gut microbiome community
Time frame: Up to 1 week
Gastrointestinal mucosal barrier index
Time frame: Up to 1 weeks
Markers of inflammatory conditions
Time frame: Up to 3 months
Inflammatory markers
Time frame: Up to 3 months
Inflammatory markers
Time frame: Up to 3 months
Inflammatory markers
Time frame: Up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FMT in people with Acute Pancreatitis and Severe Acute Pancreatitis, run by Changhai Hospital at 2 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 7 inclusion and 12 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 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Kong Xiang yu, associate professor (13564644397, xiangyukong185@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pancreatic infectious complications (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2025.