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Clinical study of live combined Bifidobacterium and Lactobacillus tablets regulating gut microbiota to prevent post-transjugular intrahepatic portosystemic shunt hepatic encephalopathy

Clinical study of live combined Bifidobacterium and Lactobacillus tablets regulating gut microbiota to prevent post-transjugular intrahepatic portosystemic shunt hepatic encephalopathy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062996
Enrollment
Unknown
Registered
2022-08-27
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

Liver cirrhosis

Interventions

Treatment group:Live Combined Bifidobacterium and Lactobacillus Tablets
Control group:No probiotics administered

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18 to 75 years; 2) Diagnosed with liver cirrhosis; 3) Receive elective TIPS.

Exclusion criteria

Exclusion criteria: 1) Severe underlying conditions involving vital organs (heart, lung, kidney, brain, hematologcial system, etc.); 2) History of overt hepatic encephalopathy or overt hepatic encephalopathy diagnosed at enrollment; 3) Previous treatments with TIPS or surgical shunt; 4) Prescribed with probiotics or prebiotics within 4 weeks before enrollment; 5) Hepatic myelopathy or other neuropsychological disorders; 6) Presence of malignancy; 7) Liver transplantation; 8) In pregnancy or lactation; 9) Poor literacy to recognize, comprehend and write simple words; 10) Complicaitons of liver cirrhosis (spontaneous bacterial peritonitis, hepatorenal syndrome, hepatopulmonary syndrome, etc.) is uncontrolled or stable less than 1 week; 11) Incompetent of reading due to compromised vision 12) Residency in high altitudes (higher than 2500 meters above the sea level); 13) Child-Pugh score exceeds 12 points or aminotransferase elevations exceeds five times of upper limits of normal; 14) Cholestatic diseases (primary biliary cirrhosis, primary sclerosing cholangitis, extrahepatic bile duct obstruction, etc.)

Design outcomes

Primary

MeasureTime frame
Hepatic encephalopathy;Gut microbiota;

Secondary

MeasureTime frame
Death, liver transplantation, and other liver cirrhosis complications;Biochemical and metabolic variables, etc;

Countries

China

Contacts

Public ContactHao Wu
594264513@qq.com+86 28 85422387

Outcome results

None listed

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