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| Name | Class |
|---|---|
| Grape King Bio Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GK#10 | Experimental | GK#10 1 pk tid for 8 weeks |
|
| Placebo | Placebo Comparator | Placebo 1 pack tid for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GK#10 | Dietary Supplement | GK#10, 1 pack tid |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Admission Due to Complications Related to Portal Hypertension | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Liver Function Evaluation | Measure ALT level of patients | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xi-Zhang Lin | Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cheng Kung University Hospital | Tainan | 70428 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18626428 | Background | 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. | |
| 17531188 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | GK#10 | GK#10 1 pk tid for 8 weeks |
| FG001 | Placebo | Placebo 1 pack tid for 8 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GK#10 | GK#10 1 pk tid for 8 weeks |
| BG001 | Placebo | Placebo 1 pack tid for 8 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Admission Due to Complications Related to Portal Hypertension | Posted | Number | participants | 8 weeks |
|
|
13 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GK#10 | GK#10 1 pk tid for 8 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Po Lin Chen | National Cheng Kung University Hospital | 886-2353535 | 4733 | n939492@mail.hosp.ncku.edu.tw |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Placebo | Drug | Placebo 1 pack tid po |
|
| 7927273 | Background | Groszmann RJ. Hyperdynamic circulation of liver disease 40 years later: pathophysiology and clinical consequences. Hepatology. 1994 Nov;20(5):1359-63. No abstract available. |
| 8439146 | Background | 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. |
| 9145446 | Background | 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. |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Reasons of cirrhosis | Number | participants |
|
| Alcoholism | Number | participants |
|
| HBV | Number | participants |
|
| HCV | Number | participants |
|
| Ascites | Number | participants |
|
| Variceal bleeding | Number | participants |
|
| Hepatic encephalopathy | Number | participants |
|
| Diabetes | Number | participants |
|
| Hypertension | Number | participants |
|
| Cerebral vascular accident | Number | participants |
|
| WBC (cells/ml) | Mean | Standard Deviation | cells/ml |
|
| Hb (g/dL) | Mean | Standard Deviation | g/dL |
|
| Platelet (x1000 platelets/μl) | Mean | Standard Deviation | x1000 platelets/uL |
|
| Cr (mg/dL) | Mean | Standard Deviation | mg/dL |
|
| Total bilirubin (mg/dL) | Bilirubin is excreted in bile and urine, and elevated levels in blood may indicate liver function impairment. | Mean | Standard Deviation | mg/dL |
|
| AST (U/L) | Mean | Standard Deviation | U/L |
|
| ALT (U/L) | Mean | Standard Deviation | U/L |
|
| Prothrombin time (seconds) | The prothrombin time are measures of the extrinsic pathway of coagulation. It is used to determine the clotting tendency of blood. The longer prothrombin time means impairment of blood coagulation. | Mean | Standard Deviation | seconds |
|
| hsCRP (mg/L) | Mean | Standard Deviation | mg/L |
|
| Malondialdehyde (μM) | Malondialdehyde (MDA) is one of the most frequently used indicators of lipid peroxidation, also a biomarker of oxidative stress. | Mean | Standard Deviation | μM |
|
| Re-admission | Number | participants |
|
| TNF-α (pg/mL) | Tumor necrosis factor alpha (TNF-α) is a cytokine involved in systemic inflammation and is a member of a group of cytokines that stimulate the acute phase reaction. | Mean | Standard Deviation | pg/mL |
|
|
|
| Secondary | Liver Function Evaluation | Measure ALT level of patients | Posted | Mean | Standard Deviation | U/L | 8 weeks |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Placebo | Placebo 1 pack tid for 8 weeks | 0 | 24 | 0 | 24 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D019602 |
| Food and Beverages |