Probiotics for Liver Cirrhosis With Portal Hypertension

Not Applicable

Completed

• Conditions: Portal Hypertension; Liver Cirrhosis
• Interventions: Dietary Supplement: GK#10; Drug: Placebo

• Registration Number: NCT01598064
• Lead Sponsor: Po-Lin Chen, MD

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-05-08
• Study First Submitted QC: 2012-05-14
• Study First Posted: 2012-05-15
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-07
• Results First Submitted: 2014-07-14
• Results First Submitted QC: 2014-08-25
• Results First Posted: 2014-09-05
• Last Update Submitted: 2014-09-09
• Last Update Posted: 2014-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GK#10	GK#10	GK#10 1 pk tid for 8 weeks
Placebo	Placebo	Placebo 1 pack tid for 8 weeks

Primary Outcome Measures

Name	Time	Method
Admission Due to Complications Related to Portal Hypertension	8 weeks

Secondary Outcome Measures

Name	Time	Method
Liver Function Evaluation	8 weeks	Measure ALT level of patients

Trial Locations

Locations (1)

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan