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The use of probiotics in prevention of hepatic encephalopathy after transjugular intrahepatic portosystemic shunt (TIPS) in liver cirrhosis patients: a multicentre randomised, double blind, placebo controlled trial

The use of probiotics in prevention of hepatic encephalopathy after transjugular intrahepatic portosystemic shunt (TIPS) in liver cirrhosis patients: a multicentre randomised, double blind, placebo controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063747
Enrollment
Unknown
Registered
2022-09-15
Start date
2022-09-15
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

Liver cirrhosis

Interventions

Experimental group:Tetralogy of viable bifidobacterium tablets
Control group:Placebo

Sponsors

Second Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-70 years old, male or female; 2. All cases refer to the 2015 guidelines for the prevention and treatment of chronic hepatitis B and the unified standard proposed by Anthony, and meet the diagnostic criteria for liver cirrhosis; 3. Signed the informed consent to participate in the research; 4. Suffering from liver cirrhosis, plan to place TIPS in the near future for the treatment of ascites or refractory pleural effusion or the prevention of gastrointestinal bleeding related to portal hypertension.

Exclusion criteria

Exclusion criteria: 1. Patients with liver cirrhosis combined with liver cancer confirmed by CT or MRI, histopathology, or gastric cancer, pancreatic cancer and other malignant tumors confirmed by histopathology; 2. Child Pugh score > 12; 3. Patients who need TIPS for other reasons; 4. Patients with liver cirrhosis combined with systemic lupus erythematosus, Crohn's disease, ulcerative colitis and other inflammatory bowel diseases; patients with liver cirrhosis combined with blood system diseases; 5. Severe heart and lung dysfunction; 6. Has a history of drinking alcohol or using antibiotics or probiotics in the past month; 7. Patients after splenectomy or splenic artery embolization; 8. Patients with a history of gastrointestinal or gastrointestinal surgery; 9. Suffering from neurological diseases, such as Alzheimer's disease, Parkinson's disease, non-hepatic metabolic encephalopathy; 10. Use of antipsychotic drugs, such as antidepressants or sedatives; 11. Patients with a history of overt hepatic encephalopathy; 12. Pregnant or lactating women; 13. Patients who have undergone liver transplantation; 14. The investigator believes that there are other patients who are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Incidence of Hepatic encephalopathy;Gut microbiota;Metabolomics;

Secondary

MeasureTime frame
Laboratory index;

Countries

China

Contacts

Public ContactShiming Yang

Xinqiao Hospital, Army Medical University

botangxq@tmmu.edu.cn+86 13228686589

Outcome results

None listed

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