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Clinical study on the treatment of recurrent hepatic encephalopathy by fecal microbiota transplantation

Clinical study on the treatment of recurrent hepatic encephalopathy by fecal microbiota transplantation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097733
Enrollment
Unknown
Registered
2025-02-25
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Hepatic encephalopathy

Interventions

fecal microbiota transplantation + standard treatment group (FMT group):After standard treatment of lactulose + aspartate ornithine ± rifaximin, after the condition stabilizes for 5-7 days, fecal micr
standard treatment group (STgroup):Lactulose 30ml once a day oral + aspartate ornithine ± rifaximin standard treatment) After the condition stabilized for 5-7 days, 40ml saline enema was given once a

Sponsors

Beijing Ditan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.18-75 years old; 2.At least two hepatic encephalopathy attacks within half a year; 3.In the recurrence of hepatic encephalopathy at the time of enrollment; 4.Good adherence to hepatic encephalopathy drugs (patients can take lactulose and rifaximin); 5.I or my guardian understand and sign written informed consent and voluntarily join this study; 6.Women of childbearing age must agree to use effective contraceptive measures during the study period, 10 days before the study and 30 days after the study; 7.Women of childbearing age have a negative pregnancy test.

Exclusion criteria

Exclusion criteria: 1.MELD score >17; 2. WBC count <1×10^9/L or platelet count <50×10^9/L; 3.Receive blood purification treatment; 4.Known untreated malignant tumors; 5.Chronic inherent gastrointestinal disease (ulcerative colon inflammation, Crohn's disease or microscopic colitis, eosinophilic gastroenteritis and celiac disease) or intestinal obstruction; 6.Major gastrointestinal or abdominal surgery within three months; 7.Continuous use of antibiotics (except rifaximin); 8.Allergic constitution; 9.Researchers believe that other conditions are not suitable for treatment with fecal bacteria transplantation.

Design outcomes

Primary

MeasureTime frame
The ratio of patients with hepatic encephalopathy above level 2 within 3 months;

Secondary

MeasureTime frame
Hepatic encephalopathy psychometric score;The incidence of events in decompensated period of cirrhosis;Readmission rate;Changes in intestinal flora and characteristic flora;

Countries

China

Contacts

Public ContactYang Song

Beijing Ditan Hospital of Capital Medical University

sduyangsong@163.com+86 150 1121 0692

Outcome results

None listed

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