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Comparison of probiotics and rifaximin in the prevention and treatment of minimal hepatic encephalopathy and their effects on intestinal flora in patients with liver cirrhosis

Comparison of probiotics and rifaximin in the prevention and treatment of minimal hepatic encephalopathy and their effects on intestinal flora in patients with liver cirrhosis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040960
Enrollment
Unknown
Registered
2020-12-16
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-04-12

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

Conditions

minimal hepatic encephalopathy

Interventions

Probiotic group:3 bid capsules of Bifidobacterium Triple Live bacteria
Rifaximin group:Rifaximin0.6g, bid
Lactulose group:Lactulose (Adjust freely according to the number of stools)

Sponsors

Department of Gastroenterology, the First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. The patient or his or her family (guardian) agrees to participate in this study and sign the informed consent form. 2. The age is from 30 to 70 years old, regardless of sex. 3. She was clinically diagnosed as liver cirrhosis and diagnosed as MHE by PHES score. 4. The condition was stable within 3 months, and there were no obvious complications of liver cirrhosis. 5. Patients are willing to accept late follow-up and other agreement requirements.

Exclusion criteria

Exclusion criteria: 1. Patients who have a pregnancy plan during pregnancy or during the trial. 2. Patients who have any doubts about the technology or have a history of other risks. 3. Patients at the end of the disease or who may die in the study. 4. Study of patients who participated in other clinical trials three months before enrollment. 5. Patients who had participated in any other flora treatment before they were enrolled in the study. 6. There are symptoms of gastrointestinal bleeding such as hematemesis and black stool or other serious complications of liver cirrhosis in the past 1 month. 7. Patients with severe cardiopulmonary, liver and renal insufficiency. 8. Had obvious history of HE or HE and had undergone transjugular intrahepatic portosystemic shunt. 9. Recently used antibiotics, lactulose, LOLA, branched chain amino acids, yogurt and probiotics. 10. Any patients who are considered by the researchers to be unable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Fecal 16s gene sequencing;ammonia;Child;HRQOL;

Secondary

MeasureTime frame
Endotoxin;

Countries

China

Contacts

Public ContactXi Chen

Department of Gastroenterology, the First Affiliated Hospital of Anhui Medical University

ayfychenxi@163.com+86 13965038586

Outcome results

None listed

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