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Prevention study for Acute Pancreatitis
Official title FMT for the Prevention of Infectious Complications in Patients With Moderately Severe and Severe Acute Pancreatitis
ClinicalTrials.gov ID: NCT07464392
What this study is testing
What is Fecal Microbiota Transplantation?
Fecal Microbiota Transplantation is an investigational medicine, given as an once-daily, being studied as a potential treatment for acute pancreatitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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...
- Disease duration of 15 to 21 days
- Already have a nasojejunal tube in place
- No absolute contraindications to fecal microbiota transplantation
You likely can't join 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...
- 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
- Quanzhou, Fujian, China
- Guangzhou, Guangdong, China
- Qingyuan, Guangdong, China
- Zhanjiang, Guangdong, China
- Shanghai, Shanghai Municipality, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China; Quanzhou, Fujian, China; Guangzhou, Guangdong, China; Qingyuan, Guangdong, China; Zhanjiang, Guangdong, China; Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.