Probiotics for Liver Cirrhosis With Portal Hypertension

NCT ID: NCT01598064

Last Updated: 2014-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-08-31

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.

Conditions

Liver Cirrhosis; Portal Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

GK#10

GK#10 1 pk tid for 8 weeks

Group Type: EXPERIMENTAL

GK#10

Intervention Type: DIETARY_SUPPLEMENT

GK#10, 1 pack tid

Placebo

Placebo 1 pack tid for 8 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo 1 pack tid po

Interventions

GK#10

GK#10, 1 pack tid

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo 1 pack tid po

Intervention Type: DRUG

Other Intervention Names

Probiotics

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grape King Bio Ltd.

INDUSTRY

Sponsor Role: collaborator

Po-Lin Chen, MD

OTHER

Sponsor Role: lead

Responsible Party

Po-Lin Chen, MD

Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xi-Zhang Lin

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

National Cheng Kung University Hospital

Tainan City, , Taiwan

Countries

Taiwan

References

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.

Reference Type: BACKGROUND

PMID: 18626428 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17531188 (View on PubMed)

Groszmann RJ. Hyperdynamic circulation of liver disease 40 years later: pathophysiology and clinical consequences. Hepatology. 1994 Nov;20(5):1359-63. No abstract available.

Reference Type: BACKGROUND

PMID: 7927273 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8439146 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9145446 (View on PubMed)

Other Identifiers

GK#10

Identifier Type: -

Identifier Source: org_study_id