Clinical trial NCT01598064: Probiotics for Liver Cirrhosis With Portal Hypertension
Official title: Clinical Trial of Probiotics in Preventing Complication Related to Portal Hypertension in Cirrhotic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cirrhosis
Portal Hypertension
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
Collaborators: name: Grape King Bio Ltd.
First posted: 2012-05-15
Enrollment: 49
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Admission Due to Complications Related to Portal Hypertension
timeFrame: 8 weeks
Secondary outcomes:
measure: Liver Function Evaluation
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: Professor
name: Xi-Zhang Lin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guerrero Hernandez I, Torre Delgadillo A, Vargas Vorackova F, Uribe M. Intestinal flora, probiotics, and cirrhosis. Ann Hepatol. 2008 Apr-Jun;7(2):120-4.
citation: De Minicis S, Brenner DA. NOX in liver fibrosis. Arch Biochem Biophys. 2007 Jun 15;462(2):266-72. doi: 10.1016/j.abb.2007.04.016. Epub 2007 May 2.
citation: Groszmann RJ. Hyperdynamic circulation of liver disease 40 years later: pathophysiology and clinical consequences. Hepatology. 1994 Nov;20(5):1359-63. No abstract available.
citation: Johansson ML, Molin G, Jeppsson B, Nobaek S, Ahrne S, Bengmark S. Administration of different Lactobacillus strains in fermented oatmeal soup: in vivo colonization of human intestinal mucosa and effect on the indigenous flora. Appl Environ Microbiol. 1993 Jan;59(1):15-20. doi: 10.1128/aem.59.1.15-20.1993.
citation: Salminen S, Salminen E. Lactulose, lactic acid bacteria, intestinal microecology and mucosal protection. Scand J Gastroenterol Suppl. 1997;222:45-8. doi: 10.1080/00365521.1997.11720717.