Probiotics for Liver Cirrhosis With Portal Hypertension

Study Overview
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Brief Summary
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Recent studies indicate that probiotics can stimulate intestinal immunity and tighten the junctions of epithelial cells. By these ways, probiotics can reduce bacterial translocation; hence, they can ameliorate systemic inflammatory status. Because cirrhotic patients with portal hypertension often suffer from infections from intestinal flora, the investigators speculate that probiotics will be beneficial to those patients.

Detailed Description
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The investigators will recruit appropriate patients, 120 in number, randomly allocate into control and experimental arms. They will be given GK#10 or placebo for 8 weeks. Clinical parameters, such as liver function, renal function, and general conditions will be evaluated at specific time points, week 0, 5, 9, and 13 weeks. Primary outcome measurement will be survival and major complications analysis, and secondary outcome measurement will be liver function evaluation. The investigators anticipate providing our sponsor with useful results about GK#10. The investigators will make clear the impacts from individual strains, the investigators will validate our speculation that probiotics do no harm to cirrhotic patients with portal hypertension, even be beneficial to them. If the investigators can validate the anticipation, patients can enjoy benefits from our study, and the probiotics may have the potential to sell to the patients in the world.

Official Title
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Clinical Trial of Probiotics in Preventing Complication Related to Portal Hypertension in Cirrhotic Patients

Conditions
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Liver Cirrhosis, Portal Hypertension

Intervention / Treatment
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* Dietary Supplement: GK#10
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with history of complications related to liver cirrhosis, including hepatic encephalopathy, variceal bleeding, and spontaneous bacterial peritonitis Patients with evidences of portal hypertension, such as hepatosplenomegaly, thrombocytopenia (< 100,000/ml) Exclusion Criteria: Active infection Dialysis patients, myocardial infarction, life-threatening cardiac arrythmia and stroke Hepatocellular carcinoma with life expectancy < 6 months Portal vein thrombosis in hepatic encephalopathy or liver function ALT > 3 x UNL, T-bilirubin > 4.0 mg/dL GI tract bleeding in recent 1 weeks Drug abuser No informed consent

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GK#10<br>GK#10 1 pk tid for 8 weeks | Dietary Supplement: GK#10<br>* GK#10, 1 pack tid<br>* Other names: Probiotics;|
| Placebo Comparator: Placebo<br>Placebo 1 pack tid for 8 weeks | Drug: Placebo<br>* Placebo 1 pack tid po<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Admission Due to Complications Related to Portal Hypertension |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver Function Evaluation | Measure ALT level of patients | 8 weeks |