Trial Outcomes & Findings for Probiotics for Liver Cirrhosis With Portal Hypertension (NCT NCT01598064)
NCT ID: NCT01598064
Last Updated: 2014-09-18
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
49 participants
Primary outcome timeframe
8 weeks
Results posted on
2014-09-18
Participant Flow
Participant milestones
| Measure |
GK#10
GK#10 1 pk tid for 8 weeks
|
Placebo
Placebo 1 pack tid for 8 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
24
|
|
Overall Study
COMPLETED
|
25
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Probiotics for Liver Cirrhosis With Portal Hypertension
Baseline characteristics by cohort
| Measure |
GK#10
n=25 Participants
GK#10 1 pk tid for 8 weeks
|
Placebo
n=24 Participants
Placebo 1 pack tid for 8 weeks
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.9 years
STANDARD_DEVIATION 12 • n=5 Participants
|
58.9 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
59.4 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
25 participants
n=5 Participants
|
24 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
Reasons of cirrhosis
CIRRHOSIS UNKNOWN REASONS
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Reasons of cirrhosis
CIRRHOSIS WITH REASONS
|
21 participants
n=5 Participants
|
21 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Alcoholism
ALCOHOLSIM
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Alcoholism
NON-ALCOHOLISM
|
23 participants
n=5 Participants
|
22 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
HBV
HBV
|
9 participants
n=5 Participants
|
11 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
HBV
NON-HBV
|
16 participants
n=5 Participants
|
13 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
HCV
HCV
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
HCV
NON-HCV
|
17 participants
n=5 Participants
|
18 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Ascites
ASCITES
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Ascites
NO ASCITES
|
16 participants
n=5 Participants
|
17 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Variceal bleeding
VARICEAL BLEEDING
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Variceal bleeding
NO VARICEAL BLEEDING
|
25 participants
n=5 Participants
|
23 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Hepatic encephalopathy
HEPATIC ENCEPHALOPATHY
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Hepatic encephalopathy
NO HEPATIC ENCEPHALOPATHY
|
23 participants
n=5 Participants
|
20 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Diabetes
DIABETES
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Diabetes
NON DIABETES
|
19 participants
n=5 Participants
|
18 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Hypertension
HYPERTENSION
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Hypertension
NON HYPERTENSION
|
21 participants
n=5 Participants
|
21 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Cerebral vascular accident
CVA
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Cerebral vascular accident
NON CVA
|
25 participants
n=5 Participants
|
24 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
WBC (cells/ml)
|
5019 cells/ml
STANDARD_DEVIATION 2027 • n=5 Participants
|
5116 cells/ml
STANDARD_DEVIATION 1815 • n=7 Participants
|
5111 cells/ml
STANDARD_DEVIATION 1886 • n=5 Participants
|
|
Hb (g/dL)
|
12.8 g/dL
STANDARD_DEVIATION 1.8 • n=5 Participants
|
13.2 g/dL
STANDARD_DEVIATION 2.1 • n=7 Participants
|
13.0 g/dL
STANDARD_DEVIATION 2.0 • n=5 Participants
|
|
Platelet (x1000 platelets/μl)
|
108.3 x1000 platelets/uL
STANDARD_DEVIATION 58.2 • n=5 Participants
|
112.3 x1000 platelets/uL
STANDARD_DEVIATION 45.9 • n=7 Participants
|
110.2 x1000 platelets/uL
STANDARD_DEVIATION 50.5 • n=5 Participants
|
|
Cr (mg/dL)
|
0.8 mg/dL
STANDARD_DEVIATION 0.3 • n=5 Participants
|
0.9 mg/dL
STANDARD_DEVIATION 0.2 • n=7 Participants
|
0.8 mg/dL
STANDARD_DEVIATION 0.3 • n=5 Participants
|
|
Total bilirubin (mg/dL)
|
1.2 mg/dL
STANDARD_DEVIATION 0.6 • n=5 Participants
|
1.2 mg/dL
STANDARD_DEVIATION 0.6 • n=7 Participants
|
1.2 mg/dL
STANDARD_DEVIATION 0.6 • n=5 Participants
|
|
AST (U/L)
|
58.4 U/L
STANDARD_DEVIATION 24.8 • n=5 Participants
|
51.1 U/L
STANDARD_DEVIATION 20.9 • n=7 Participants
|
54.6 U/L
STANDARD_DEVIATION 22.5 • n=5 Participants
|
|
ALT (U/L)
|
48.2 U/L
STANDARD_DEVIATION 29.3 • n=5 Participants
|
39.5 U/L
STANDARD_DEVIATION 21.3 • n=7 Participants
|
43.6 U/L
STANDARD_DEVIATION 25.0 • n=5 Participants
|
|
Prothrombin time (seconds)
|
12.4 seconds
STANDARD_DEVIATION 1.1 • n=5 Participants
|
11.8 seconds
STANDARD_DEVIATION 1.5 • n=7 Participants
|
12.3 seconds
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
hsCRP (mg/L)
|
7.1 mg/L
STANDARD_DEVIATION 0.5 • n=5 Participants
|
7.4 mg/L
STANDARD_DEVIATION 1.3 • n=7 Participants
|
7.2 mg/L
STANDARD_DEVIATION 0.9 • n=5 Participants
|
|
Malondialdehyde (μM)
|
0.6 μM
STANDARD_DEVIATION 0.2 • n=5 Participants
|
0.6 μM
STANDARD_DEVIATION 0.2 • n=7 Participants
|
0.6 μM
STANDARD_DEVIATION 0.2 • n=5 Participants
|
|
Re-admission
Re-admission
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Re-admission
No re-admission
|
23 participants
n=5 Participants
|
21 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
TNF-α (pg/mL)
|
12.0 pg/mL
STANDARD_DEVIATION 3.9 • n=5 Participants
|
10.8 pg/mL
STANDARD_DEVIATION 2.9 • n=7 Participants
|
11.4 pg/mL
STANDARD_DEVIATION 3.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksOutcome measures
| Measure |
GK#10
n=25 Participants
GK#10 1 pk tid for 8 weeks
|
Placebo
n=24 Participants
Placebo 1 pack tid for 8 weeks
|
|---|---|---|
|
Admission Due to Complications Related to Portal Hypertension
|
2 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 8 weeksMeasure ALT level of patients
Outcome measures
| Measure |
GK#10
n=16 Participants
GK#10 1 pk tid for 8 weeks
|
Placebo
n=19 Participants
Placebo 1 pack tid for 8 weeks
|
|---|---|---|
|
Liver Function Evaluation
|
48.9 U/L
Standard Deviation 30.1
|
39.2 U/L
Standard Deviation 19.4
|
Adverse Events
GK#10
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place