Probiotics for Liver Cirrhosis With Portal Hypertension

Po-Lin Chen, MD

Status: Completed

Conditions: Portal Hypertension; Liver Cirrhosis

Treatments: Dietary Supplement: GK#10; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01598064

GK#10

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 49 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with history of complications related to liver cirrhosis, including hepatic encephalopathy, variceal bleeding, and spontaneous bacterial peritonitis
2. Patients with evidences of portal hypertension, such as hepatosplenomegaly, thrombocytopenia (< 100,000/ml)

Exclusion criteria

1. Active infection
2. Dialysis patients, myocardial infarction, life-threatening cardiac arrythmia and stroke
3. Hepatocellular carcinoma with life expectancy < 6 months
4. Portal vein thrombosis
5. in hepatic encephalopathy or liver function ALT > 3 x UNL, T-bilirubin > 4.0 mg/dL
6. GI tract bleeding in recent 1 weeks
7. Drug abuser
8. No informed consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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49 participants in 2 patient groups, including a placebo group

GK#10

Experimental group

Description:

GK#10 1 pk tid for 8 weeks

Treatment:

Dietary Supplement: GK#10

Placebo

Placebo Comparator group

Description:

Placebo 1 pack tid for 8 weeks

Treatment:

Drug: Placebo