NCT01598064

Probiotics for Liver Cirrhosis With Portal Hypertension

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Po-Lin Chen, MD · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Cirrhosis
• Portal Hypertension

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	GK#10	GK#10, 1 pack tid
DRUG	Placebo	Placebo 1 pack tid po

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2012-05-15
• Last updated: 2014-09-18
• Results posted: 2014-09-05

Locations

1 site across 1 country: Taiwan