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
About this trial
This is an interventional prevention trial for Liver Cirrhosis
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
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
NCT ID
NCT01598064
First Posted
May 8, 2012
Last Updated
September 9, 2014
Sponsor
Po-Lin Chen, MD
Collaborators
Grape King Bio Ltd.
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
background
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
background
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
background
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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