Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-26 @ 10:59 AM
NCT ID:
NCT03161106
Eligibility Criteria:
Inclusion Criteria:
1. Liver cirrhosis (Child B or Child C class)
2. Age between 18-60 years
3. History of recovery from episodeof overt hepatic encephalopathy (West-Haven grade 1 and above) in last 12 months.
Exclusion Criteria:
1. Evidence of overt hepatic encephalopathy at the time of enrollment
2. History of taking lactulose, rifaximin, neomycin, metronidazole, L-Ornithine L-Aspartate or probiotics in past 7 days
3. Alcohol intake during past 6 weeks
4. Receiving secondary prophylaxis for spontaneous bacterial peritonitis
5. Previous transjugular intrahepatic portosystemic shunts or shunt surgery
6. Significant comorbid illness such as heart, respiratory or kidney failure, and neurological disease such as Alzheimer's disease, Parkinson's disease and non hepatic metabolic encephalopathies
7. Receiving psychoactive drugs, promotility and hypomotility drugs
8. Hepatocellular carcinoma
9. Electrolyte abnormality (Serum sodium \<125meq/L or serum potassium \<2.5meq/L)
10. Intercurrent infection such as spontaneous bacterial peritonitis
11. Patients of acute on chronic liver failure (ACLF).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03161106
Study Brief:
Protocol Section:
NCT03161106