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OpenTrials
Completed

NCT Number: NCT01598064

Probiotics for Liver Cirrhosis With Portal Hypertension

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University Hospital

Tainan, 70428, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GK#10

Dietary Supplement

GK#10, 1 pack tid

Other names: Probiotics

Placebo

Drug

Placebo 1 pack tid po

Primary outcomes

  1. Admission Due to Complications Related to Portal Hypertension

    Time frame: 8 weeks

Secondary outcomes

  1. Liver Function Evaluation

    Time frame: 8 weeks

    Measure ALT level of patients

Sponsors and collaborators

Lead sponsor

Po-Lin Chen, MD

Other

Collaborators

  • Grape King Bio Ltd.

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 15, 2012
Registry last updated
Sep 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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