cirrhosis with minimal hepatic encephalopathy
Conditions
Interventions
active treatment:Lactulose Oral Solution
Sponsors
Zhong Shan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years old; 2. Gender not limited; 3. Patients hospitalized with cirrhosis confirmed by pathology or imaging, with both NCT and DST test positive results complying with MHE diagnostic criteria; 4. Patient or his/her family (guardian) agrees to participate in this study, and signs the Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed as overt HE (grade >=1) 2. Patients who are unable to complete NCT and DST tests due to mental factors, nervous system diseases, intelligence or eyesight, or who are unable to complete the form for evaluating the quality of life; 3. Patients with cirrhosis caused by chronic alcoholism; 4. Patients with cirrhosis caused by Wilson’s disease or other genetic metabolic diseases with the nerve system affected; 5. Patients with history of GI surgery or TIPS; 6. Pregnant or lactating patients; 7. Patients with galactosemia; 8. Patients with intestinal obstruction and acute abdominal pain; 9. Patients who are allergic to lactulose and its components; 10. Patients who are in the combined use of other cathartics; 11. Patients who are in the combined use of other blood ammonia reducing drugs (e.g. sodium glutamate, potassium glutamate, arginine and Ornithine Aspartate Injection) and receive plasma exchange treatment; 12. Patients who have taken the following drugs within 4 weeks before the study starts: antibiotics, PPI, prokinetic drugs and probiotics including yoghourt and et al. 13. Patients with acute diarrhea 1 week before the study begins 14. Patients with chronic diarrhea 15. Patients who have had electrolyte (sodium, potassium, chlorin) disturbance 16. Patients who have melena, hematemesis and other symptoms of gastrointestinal bleeding within 2 weeks before the study begins; 17. Patients who have other diseases that may affect this study, including patients who have severe cardiopulmonary diseases, diabetes, tumor, immune system diseases, and patients who have to receive long-term hormone treatment due to other diseases; 18. Substance abuse: excessive drinking (>=80 g/day), medicine (drug) taking via vein or inhalation in the past two years; 19. Patients with chronic viral hepatitis who begin to receive antiviral therapy within the past six months 20. Any patient who is deemed unqualified by investigators to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recovery rate of NCT and DS; | — |
Secondary
| Measure | Time frame |
|---|---|
| QOL assessmen; | — |
Countries
China
Contacts
Public ContactWang Jiyao
Zhong Shan Hospital, Fudan University, Shanghai, China
Outcome results
None listed