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Probiotics for Liver Cirrhosis With Portal Hypertension

Primary Purpose

Liver Cirrhosis, Portal Hypertension

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
GK#10
Placebo
Sponsored by
Po-Lin Chen, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Liver Cirrhosis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Cheng Kung University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GK#10

Placebo

Arm Description

GK#10 1 pk tid for 8 weeks

Placebo 1 pack tid for 8 weeks

Outcomes

Primary Outcome Measures

Admission Due to Complications Related to Portal Hypertension

Secondary Outcome Measures

Liver Function Evaluation
Measure ALT level of patients

Full Information

First Posted
May 8, 2012
Last Updated
September 9, 2014
Sponsor
Po-Lin Chen, MD
Collaborators
Grape King Bio Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01598064
Brief Title
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

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Po-Lin Chen, MD
Collaborators
Grape King Bio Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Portal Hypertension

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GK#10
Arm Type
Experimental
Arm Description
GK#10 1 pk tid for 8 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 1 pack tid for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
GK#10
Other Intervention Name(s)
Probiotics
Intervention Description
GK#10, 1 pack tid
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 1 pack tid po
Primary Outcome Measure Information:
Title
Admission Due to Complications Related to Portal Hypertension
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Liver Function Evaluation
Description
Measure ALT level of patients
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xi-Zhang Lin
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70428
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
18626428
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.
Results Reference
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PubMed Identifier
17531188
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.
Results Reference
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PubMed Identifier
7927273
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.
Results Reference
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PubMed Identifier
8439146
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.
Results Reference
background
PubMed Identifier
9145446
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.
Results Reference
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Probiotics for Liver Cirrhosis With Portal Hypertension

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