Trial Outcomes & Findings for A Trial to Improve Quality of Life in People With Cirrhosis (NCT NCT05061992)
NCT ID: NCT05061992
Last Updated: 2023-11-21
Results Overview
The SF-8 is an abbreviated version of an original 36-item health survey (SF-36). It is a generic, multipurpose, quality of life instrument, containing psychometrically based physical and mental health summary measures. The eight domains are general health, physical functioning, role physical, bodily pain, vitality, social functioning, mental health, and role emotional. Scores from the domains are combined and range from 0 (lowest quality of living) to 100 (highest quality of living).
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
56 participants
Primary outcome timeframe
28 days
Results posted on
2023-11-21
Participant Flow
Participant milestones
| Measure |
Lactulose
Lactulose: Participants will take 20 grams (dissolved in 4ounces of water/beverage) doses of lactulose twice daily (upon awakening and then 4 hours later) for 28 days.
In addition, outcome measurements will be completed at baseline and day 28.
|
No Treatment
Subjects will complete baseline and outcome assessments at 28 days and no intervention or placebo will be prescribed.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
|
Overall Study
COMPLETED
|
25
|
27
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Lactulose
Lactulose: Participants will take 20 grams (dissolved in 4ounces of water/beverage) doses of lactulose twice daily (upon awakening and then 4 hours later) for 28 days.
In addition, outcome measurements will be completed at baseline and day 28.
|
No Treatment
Subjects will complete baseline and outcome assessments at 28 days and no intervention or placebo will be prescribed.
|
|---|---|---|
|
Overall Study
Excess bowel movements
|
1
|
0
|
|
Overall Study
Complications of Medical Care
|
1
|
0
|
|
Overall Study
Diarrhea Prior to Starting Therapy
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Trial to Improve Quality of Life in People With Cirrhosis
Baseline characteristics by cohort
| Measure |
Lactulose
n=28 Participants
Lactulose: Participants will take 20 grams (dissolved in 4ounces of water/beverage) doses of lactulose twice daily (upon awakening and then 4 hours later) for 28 days.
In addition, outcome measurements will be completed at baseline and day 28.
|
No Treatment
n=28 Participants
Subjects will complete baseline and outcome assessments at 28 days and no intervention or placebo will be prescribed.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
58.1 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
61.8 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
60.0 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Short Form-8 Health Survey (SF-8)
|
57.2 score on a scale
STANDARD_DEVIATION 18.3 • n=5 Participants
|
61.1 score on a scale
STANDARD_DEVIATION 17.0 • n=7 Participants
|
59.2 score on a scale
STANDARD_DEVIATION 17.7 • n=5 Participants
|
|
Animal Naming Test
|
17.9 Count of Animals Named
STANDARD_DEVIATION 5.3 • n=5 Participants
|
18.3 Count of Animals Named
STANDARD_DEVIATION 6.5 • n=7 Participants
|
18.1 Count of Animals Named
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Sleep Quality
|
2.5 Score on a Scale
STANDARD_DEVIATION 0.8 • n=5 Participants
|
2.5 Score on a Scale
STANDARD_DEVIATION 0.8 • n=7 Participants
|
2.5 Score on a Scale
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Activity Impairment
|
5.4 Score on a Scale
STANDARD_DEVIATION 1.9 • n=5 Participants
|
5.7 Score on a Scale
STANDARD_DEVIATION 2.1 • n=7 Participants
|
5.6 Score on a Scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Participants Who Fell in Past 90 Days
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysThe SF-8 is an abbreviated version of an original 36-item health survey (SF-36). It is a generic, multipurpose, quality of life instrument, containing psychometrically based physical and mental health summary measures. The eight domains are general health, physical functioning, role physical, bodily pain, vitality, social functioning, mental health, and role emotional. Scores from the domains are combined and range from 0 (lowest quality of living) to 100 (highest quality of living).
Outcome measures
| Measure |
Lactulose
n=25 Participants
Lactulose: Participants will take 20 grams (dissolved in 4ounces of water/beverage) doses of lactulose twice daily (upon awakening and then 4 hours later) for 28 days.
In addition, outcome measurements will be completed at baseline and day 28.
|
No Treatment
n=27 Participants
Subjects will complete baseline and outcome assessments at 28 days and no intervention or placebo will be prescribed.
|
|---|---|---|
|
Short Form-8 Health Survey (SF-8) at 28 Days
Change in SF-8 from Baseline
|
8.1 score on a scale
Interval 3.7 to 12.4
|
6.55 score on a scale
Interval 2.3 to 10.8
|
|
Short Form-8 Health Survey (SF-8) at 28 Days
End of Trial SF-8
|
70.9 score on a scale
Interval 63.9 to 77.9
|
63.84 score on a scale
Interval 57.1 to 70.6
|
SECONDARY outcome
Timeframe: 28 daysNumber of unique animals named within 1 minute by the participant. Values below show the change from baseline and the results from the test taken 28 days later.
Outcome measures
| Measure |
Lactulose
n=25 Participants
Lactulose: Participants will take 20 grams (dissolved in 4ounces of water/beverage) doses of lactulose twice daily (upon awakening and then 4 hours later) for 28 days.
In addition, outcome measurements will be completed at baseline and day 28.
|
No Treatment
n=27 Participants
Subjects will complete baseline and outcome assessments at 28 days and no intervention or placebo will be prescribed.
|
|---|---|---|
|
Animal Naming Test (ANT)
Change in ANT
|
3.7 Count of Animals Named
Interval 2.1 to 5.4
|
-0.15 Count of Animals Named
Interval -1.7 to 1.4
|
|
Animal Naming Test (ANT)
End of trial ANT
|
21.2 Count of Animals Named
Interval 18.9 to 23.6
|
18.52 Count of Animals Named
Interval 16.3 to 20.8
|
SECONDARY outcome
Timeframe: Change between baseline (day 0) and 28 daysOverall sleep quality was measured on a 5-point Likert scale, with a range of 1 (very bad sleep quality) to 5 (very good sleep quality).
Outcome measures
| Measure |
Lactulose
n=25 Participants
Lactulose: Participants will take 20 grams (dissolved in 4ounces of water/beverage) doses of lactulose twice daily (upon awakening and then 4 hours later) for 28 days.
In addition, outcome measurements will be completed at baseline and day 28.
|
No Treatment
n=27 Participants
Subjects will complete baseline and outcome assessments at 28 days and no intervention or placebo will be prescribed.
|
|---|---|---|
|
Change in Overall Sleep Quality
|
0.4 score on a scale
Interval 0.1 to 0.7
|
0.0 score on a scale
Interval -0.3 to 0.3
|
SECONDARY outcome
Timeframe: 28 daysSingle-question survey given to participants at baseline and again 28 days later. Participants ranked their daily activity impairment on a Likert scale of 0 (no impairment) to 10 (complete impairment)
Outcome measures
| Measure |
Lactulose
n=25 Participants
Lactulose: Participants will take 20 grams (dissolved in 4ounces of water/beverage) doses of lactulose twice daily (upon awakening and then 4 hours later) for 28 days.
In addition, outcome measurements will be completed at baseline and day 28.
|
No Treatment
n=27 Participants
Subjects will complete baseline and outcome assessments at 28 days and no intervention or placebo will be prescribed.
|
|---|---|---|
|
Regular Daily Activity Impairment
|
3.0 score on a scale
Interval 1.9 to 4.0
|
4.8 score on a scale
Interval 3.8 to 5.8
|
SECONDARY outcome
Timeframe: 28 daysYes or no question on whether participant had experienced at least 1 fall in the past 28 days.
Outcome measures
| Measure |
Lactulose
n=25 Participants
Lactulose: Participants will take 20 grams (dissolved in 4ounces of water/beverage) doses of lactulose twice daily (upon awakening and then 4 hours later) for 28 days.
In addition, outcome measurements will be completed at baseline and day 28.
|
No Treatment
n=27 Participants
Subjects will complete baseline and outcome assessments at 28 days and no intervention or placebo will be prescribed.
|
|---|---|---|
|
Participants Who Fell
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 28 daysResults show the percentage of days in a 28-day span in which participants experienced more than 5 daily bowel movements. All participants analyzed in each arm were included in calculating the results using the following formula: (days with \>5 bowel movements) / (patient-days in study) The results are presented as a single number because they are a point estimate of a population level proportion
Outcome measures
| Measure |
Lactulose
n=25 Participants
Lactulose: Participants will take 20 grams (dissolved in 4ounces of water/beverage) doses of lactulose twice daily (upon awakening and then 4 hours later) for 28 days.
In addition, outcome measurements will be completed at baseline and day 28.
|
No Treatment
n=27 Participants
Subjects will complete baseline and outcome assessments at 28 days and no intervention or placebo will be prescribed.
|
|---|---|---|
|
Daily Bowel Movements
|
5 % of participant-days with >5 bowels
|
2 % of participant-days with >5 bowels
|
Adverse Events
Lactulose
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
No Treatment
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lactulose
n=28 participants at risk
Lactulose: Participants will take 20 grams (dissolved in 4ounces of water/beverage) doses of lactulose twice daily (upon awakening and then 4 hours later) for 28 days.
In addition, outcome measurements will be completed at baseline and day 28.
|
No Treatment
n=28 participants at risk
Subjects will complete baseline and outcome assessments at 28 days and no intervention or placebo will be prescribed.
|
|---|---|---|
|
Hepatobiliary disorders
Complications from Liver Disease
|
3.6%
1/28 • 28 days
|
3.6%
1/28 • 28 days
|
Other adverse events
| Measure |
Lactulose
n=28 participants at risk
Lactulose: Participants will take 20 grams (dissolved in 4ounces of water/beverage) doses of lactulose twice daily (upon awakening and then 4 hours later) for 28 days.
In addition, outcome measurements will be completed at baseline and day 28.
|
No Treatment
n=28 participants at risk
Subjects will complete baseline and outcome assessments at 28 days and no intervention or placebo will be prescribed.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fall
|
3.6%
1/28 • 28 days
|
10.7%
3/28 • 28 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place