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A randomized, double-blind, controlled clinical trial of live combined bifidobacterium and lactobacillus tablets in the prevention of hepatic encephalopathy in cirrhotic patients

A randomized, double-blind, controlled clinical trial of live combined bifidobacterium and lactobacillus tablets in the prevention of hepatic encephalopathy in cirrhotic patients

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050743
Enrollment
Unknown
Registered
2021-09-03
Start date
2021-09-30
Completion date
Unknown
Last updated
2022-05-02

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

Conditions

Hepatic encephalopathy

Interventions

Test group:live combined bifidobacterium and lactobacillus tablets
Control group:Placebo

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years; 2. Patients with cirrhosis who have had at least one episode of overt hepatic encephalopathy (HE) (West-haven HE>=2) in the past 6 months, excluding hepatic encephalopathy episodes that were considered to be caused by gastrointestinal bleeding, drugs, dialysis for renal failure, or central nervous system injury; 3. West-Haven HE was 0 or 1 at enrollment, and the Model for End-Stage Liver Disease (MELD) score was less than or equal to 25. 4. Patients who voluntarily sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with severe heart, lung, kidney (creatinine > 177umol/L), blood, endocrine system, and mental and nervous system diseases; 2. Include those who plan to undergo liver transplantation within 1 month; 3. Those who underwent transjugular intrahepatic portosystemic shunt within the first 3 months; 4. Severe hypokalemia (K<2.5mmol.L); 5. Serious infection occurs; 6. Gastrointestinal bleeding at the time of inclusion and after inclusion; 7. Those who have allergies and idiosyncratic reactions to Bifidobacterium Lactobacillus triple viable bacteria tablets.

Design outcomes

Primary

MeasureTime frame
Recurrence rate of hepatic encephalopathy;

Secondary

MeasureTime frame
hospitalization rate;serum bilirubin level;serum albumin level;alanine aminotransferase level;aspartate aminotransferase level;Endotoxin Level;fecal flora;Blood ammonia levels;

Countries

China

Contacts

Public ContactYang Wenjuan

West China Hospital, Sichuan University

yangwenjuan19860@163.com+86 18980853964

Outcome results

None listed

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