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Early SIRS-Triggered Fecal Microbiota Transplantation to Mitigate Disease Severity in Hypertriglyceridemic Acute Pancreatitis: A Prospective, Randomized Controlled Study

Early SIRS-Triggered Fecal Microbiota Transplantation to Mitigate Disease Severity in Hypertriglyceridemic Acute Pancreatitis: A Prospective, Randomized Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117880
Enrollment
Unknown
Registered
2026-01-29
Start date
2026-01-30
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertriglyceridemic Acute Pancreatitis

Interventions

Experimental group:Standard treatment + fecal microbiota transplantation
Control group:Standard treatment

Sponsors

Xuanwu Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of hypertriglyceridemic acute pancreatitis with SIRS; 2. The first FMT can be completed within 6 hours after enrollment and there is no organ failure at the time of administration; 3. Age 18 to 65 years old, male or female; 4. Patients or their families agree to participate in the study and sign the informed consent form, and the compliance and tolerability are good.

Exclusion criteria

Exclusion criteria: 1. Contraindications for FMT: severe immunodeficiency or malignant tumors, active gastrointestinal bleeding and perforation, toxic megacolon, severe intestinal obstruction, active systemic infection, severe coagulation disorders; 2. Use of antibiotics, probiotics, or fecal transplantation within the past month; 3. Severe intestinal diseases (active Crohn's disease, active ulcerative colitis, short bowel syndrome, active intestinal fistula); 4. Severe underlying diseases (severe heart, lung, liver, or kidney dysfunction, as well as patients with impaired consciousness or coma); 5. Mental disorders, cognitive impairment, or inability to comply and follow up.

Design outcomes

Primary

MeasureTime frame
Difference in improvement rate of inflammatory markers (C-reactive protein) between the experimental and control groups during the baseline period and post-treatment;

Secondary

MeasureTime frame
Incidence of adverse events associated with faecal microbiota transplantation during hospitalisation;Inpatient surgical/endoscopic intervention rate, antibiotic utilisation rate, organ support rate;The incidence of persistent organ failure during hospitalisation;Serum metabolite alterations, gut microbiota changes;ICU occupancy rate during hospitalisation, length of stay, total treatment costs;Incidence of systemic complications during hospitalisation;90-day recurrence rate of pancreatitis and all-cause mortality;Incidence of local complications within 90 days;Laboratory parameters (rate of reduction in serum triglyceride levels, time to achieve target levels; levels of other inflammatory markers (procalcitonin, interleukin-6, erythrocyte sedimentation rate;AP-related scores (BISAP score, modified CT severity index, SOFA score, AGI grading score);

Countries

China

Contacts

Public ContactHuihong Zhai

Xuanwu Hospital, Capital Medical University

Zhaihuihong@263.net+86 10 8319 8438

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026