NCT01598064

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 8, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 15, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 5, 2014

Completed
Last Updated

September 18, 2014

Status Verified

July 1, 2014

Enrollment Period

1.3 years

First QC Date

May 8, 2012

Results QC Date

July 14, 2014

Last Update Submit

September 9, 2014

Conditions

Liver CirrhosisPortal Hypertension

Outcome Measures

Primary Outcomes (1)

  • Admission Due to Complications Related to Portal Hypertension

    8 weeks

Secondary Outcomes (1)

  • Liver Function Evaluation

    8 weeks

Study Arms (2)

GK#10

EXPERIMENTAL

GK#10 1 pk tid for 8 weeks

Dietary Supplement: GK#10

Placebo

PLACEBO COMPARATOR

Placebo 1 pack tid for 8 weeks

Drug: Placebo

Interventions

GK#10DIETARY_SUPPLEMENT

GK#10, 1 pack tid

Also known as: Probiotics
GK#10
PlaceboDRUG

Placebo 1 pack tid po

Placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 70428, Taiwan

Location

Related Publications (5)

  • 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.

    PMID: 18626428BACKGROUND

  • 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.

    PMID: 17531188BACKGROUND

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

    PMID: 7927273BACKGROUND

  • 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.

    PMID: 8439146BACKGROUND

  • 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.

    PMID: 9145446BACKGROUND

MeSH Terms

Conditions

Liver CirrhosisHypertension, Portal

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Results Point of Contact

Title
Dr. Po Lin Chen
Organization
National Cheng Kung University Hospital
n939492@mail.hosp.ncku.edu.tw
886-2353535

Study Officials

  • Xi-Zhang Lin

    Professor

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 8, 2012

First Posted

May 15, 2012

Study Start

April 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

September 18, 2014

Results First Posted

September 5, 2014

Record last verified: 2014-07

Locations

TW(1)