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Safety, efficacy and prognosis of fecal microbiota transplant in the treatment of minimal hepatic encephalopathy.

Safety, efficacy and prognosis of fecal microbiota transplant in the treatment of minimal hepatic encephalopathy.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091613
Enrollment
Unknown
Registered
2024-10-31
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-11-04

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

Conditions

Minimal hepatic encephalopathy

Interventions

Treatment group:1.Pre-treatment gut preparation:the patient will receive three days of oral Vancomycin and gentamicin for intestinal elution, then they will be treated with fecal microbiota transplant
Control Group:The patient will receive three days of oral Vancomycin and gentamicin for intestinal elution, then they will take empty capsules without fecal bacteria.The course of empty capsules is 4

Sponsors

The Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.According to the 2019 Guidelines for the Diagnosis and Treatment of Cirrhosis, the patient was diagnosed with cirrhosis through imaging or histopathology, and the subject was a fully civil person who was capable of understanding the characteristics of the clinical trial; 2. Patients are assessed for MHE using Number connection test, Digit symbol test and brain magnetic resonance, in which any two tests are abnormal and the magnetic resonance is abnormal can diagnose MHE.

Exclusion criteria

Exclusion criteria: 1. Patients with brain diseases such as cerebral hemorrhage, cerebral infarction, brain tumor, intracranial infection, epilepsy, etc.; Patients with metabolic encephalopathy such as ketoacidosis, hypoglycemia, renal encephalopathy, and pulmonary encephalopathy; Patients with alcoholic encephalopathy, heavy metal toxic encephalopathy, withdrawal syndrome and other toxic encephalopathy; 2. Patients with a history of psychosis; 3. Patients with overt hepatic encephalopathy; 4. Patients with diabetes, severe cardiopulmonary diseases, renal insufficiency, thyroid diseases, intestinal obstruction and other diseases which are easy to cause gastrointestinal insufficiency; Patients with lactose intolerance; Patients with other extrahepatic diseases which can lead to malnutrition, chronic diarrhea, etc.; Patients with a history of gastrointestinal bleeding within 6 weeks; Patients with persistent active infection; 5. Patients who have undergone abdominal surgery such as gastric and intestinal resection; 6. Patients with hearing and visual impairments who cannot undergo number connection test, digit symbol test; 7. Patients with poor compliance and other factors that may affect the results of this experiment.

Design outcomes

Primary

MeasureTime frame
psychometric hepatic encephalopathy score,PHES;Microbiological analysis of feces;Blood ammonia;NCT-A;NCT-B;DST;

Countries

China

Contacts

Public ContactBin Cao

The Affiliated Hospital of Qingdao University

caobin@qdu.edu.cn+86 186 6180 6527

Outcome results

None listed

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