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A prospective, randomized, double-blind clinical trial of fecal microbiota transplantation in patients with decompensated cirrhosis

A prospective, randomized, double-blind clinical trial of fecal microbiota transplantation in patients with decompensated cirrhosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002613
Enrollment
Unknown
Registered
2025-12-30
Start date
2026-01-05
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

decompensated cirrhosis

Interventions

FMT group:Administration of 4 capsules of human-derived active gut microbiota orally twice daily, continuously for six days per treatment course. Three treatment courses are administered at 3-week int
Placebo control group:Administration of 4 placebo capsules orally twice daily, continuously for six days per treatment course. Three treatment courses are administered at 3-week intervals, alongside c

Sponsors

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of decompensated cirrhosis. 2. Age: 18–75 years. 3. Undergoing or planning to receive etiology-targeted treatment for liver cirrhosis (e.g., antiviral therapy, alcohol abstinence). 4. Child-Pugh class B or C, or Model for End-Stage Liver Disease (MELD) score between 10 and 30. 5. Voluntarily participates in the study, signs the informed consent form, strictly adheres to the intervention protocol, and attends follow-up visits as required to provide samples and clinical data.

Exclusion criteria

Exclusion criteria: 1. Presence of severe contraindications to fecal microbiota transplantation (FMT), such as sepsis, severe intestinal barrier compromise (e.g., active massive gastrointestinal bleeding, perforation), fulminant colitis, or immunodeficiency. 2. Concurrent severe comorbidities including type 1 diabetes mellitus, major cardiovascular/cerebrovascular diseases, hepatic/renal insufficiency, malignancy, psychiatric disorders, or autoimmune diseases. 3. Pregnancy or lactation. 4. Expected survival < 6 months. 5. Use of immunosuppressants, probiotics, or other agents affecting gut microbiota within the past two weeks. 6. Other exclusion criteria: known allergy to FMT, inability to comply with study procedures, or investigator-determined unsuitability for participation.

Design outcomes

Primary

MeasureTime frame
MELD score;Child-Pugh classification;—

Secondary

MeasureTime frame
TBIL;SCr;INR;Hepatic encephalopathy;Ascites ultrasound;ALB;PT;Gut microbiota;SCFA;Cytokines;upper abdominal enhanced MRI;WBC;GGT;AST;Liver Fibroscan;Recompensation rate;Quality of life scale;AFP;MRE;HBV DNA;HBeAb;HBsAb;HBeAg;HBcAb;Upper abdominal ultrasound;AFP-L3;HA;PCIII;CIV;LN;ALP;ALT;BUN;PLT;FIB4 index;HGB;APRI score;RBC;PAB;HBsAg(includ dilution);—

Countries

China

Contacts

Public ContactGao Yueqiu

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

gaoyueqiu@hotmail.com+8613795388789

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026