Probiotics for Liver Cirrhosis With Portal Hypertension

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01598064
• Other study ID #: GK#10
• Status: Completed
• Phase: N/A
• First received: May 8, 2012
• Last updated: September 9, 2014
• Start date: April 2012
• Est. completion date: August 2013

Study information

• Verified date: July 2014
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension

Intervention

Dietary Supplement:
• GK#10
GK#10, 1 pack tid

Drug:
• Placebo
Placebo 1 pack tid po

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	Tainan

Sponsors (2)

Lead Sponsor	Collaborator
Po-Lin Chen, MD	GRAPE KING INC TAIWAN

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

De Minicis S, Brenner DA. NOX in liver fibrosis. Arch Biochem Biophys. 2007 Jun 15;462(2):266-72. Epub 2007 May 2. Review. — View Citation

Groszmann RJ. Hyperdynamic circulation of liver disease 40 years later: pathophysiology and clinical consequences. Hepatology. 1994 Nov;20(5):1359-63. Review. — View Citation

Guerrero Hernández I, Torre Delgadillo A, Vargas Vorackova F, Uribe M. Intestinal flora, probiotics, and cirrhosis. Ann Hepatol. 2008 Apr-Jun;7(2):120-4. Review. — View Citation

Johansson ML, Molin G, Jeppsson B, Nobaek S, Ahrné 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. — View Citation

Salminen S, Salminen E. Lactulose, lactic acid bacteria, intestinal microecology and mucosal protection. Scand J Gastroenterol Suppl. 1997;222:45-8. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Admission Due to Complications Related to Portal Hypertension		8 weeks	No
Secondary	Liver Function Evaluation	Measure ALT level of patients	8 weeks	No