Trial Outcomes & Findings for Novel Therapies in Moderately Severe Acute Alcoholic Hepatitis (NCT NCT01922895)
NCT ID: NCT01922895
Last Updated: 2022-03-02
Results Overview
Change in MELD scoring system for assessing the severity of chronic liver disease; MELD (Model of End Stage Liver Disease) scoring system for assessing the severity of chronic liver disease; calculated from serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) MELD = 3.8\[Ln serum bilirubin (mg/dL)\] + 11.2\[Ln INR\] + 9.6\[Ln serum creatinine (mg/dL)\] + 6.4. MELD score range from 6-40 with higher scores indicating more severe liver disease and a worse outcome.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
30 days
Results posted on
2022-03-02
Participant Flow
Participant milestones
| Measure |
Lactobacillus Rhamnosus GG
Dietary supplement capsule (Lactobacillus Rhamnosus GG) will be given once daily for 180 days.
Lactobacillus Rhamnosus GG: Probiotic nutritional supplement; Lactobacillus Rhamnosus GG
|
Placebo for Probiotic
Placebo capsule that matches the probiotic capsule in appearance will be given once daily for 180 days.
Placebo for Probiotic: Capsule manufactured without active ingredients.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
21
|
|
Overall Study
COMPLETED
|
18
|
7
|
|
Overall Study
NOT COMPLETED
|
6
|
14
|
Reasons for withdrawal
| Measure |
Lactobacillus Rhamnosus GG
Dietary supplement capsule (Lactobacillus Rhamnosus GG) will be given once daily for 180 days.
Lactobacillus Rhamnosus GG: Probiotic nutritional supplement; Lactobacillus Rhamnosus GG
|
Placebo for Probiotic
Placebo capsule that matches the probiotic capsule in appearance will be given once daily for 180 days.
Placebo for Probiotic: Capsule manufactured without active ingredients.
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
5
|
11
|
Baseline Characteristics
Novel Therapies in Moderately Severe Acute Alcoholic Hepatitis
Baseline characteristics by cohort
| Measure |
Lactobacillus Rhamnosus GG
n=24 Participants
Dietary supplement capsule (Lactobacillus Rhamnosus GG) will be given once daily for 180 days.
Lactobacillus Rhamnosus GG: Probiotic nutritional supplement; Lactobacillus Rhamnosus GG
|
Placebo for Probiotic
n=21 Participants
Placebo capsule that matches the probiotic capsule in appearance will be given once daily for 180 days.
Placebo for Probiotic: Capsule manufactured without active ingredients.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
44.2 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
45.0 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
44.6 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 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
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
41 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
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
21 participants
n=7 Participants
|
45 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: Four subjects from the LGG group and 8 subjects from the placebo group were lost to follow-up.
Change in MELD scoring system for assessing the severity of chronic liver disease; MELD (Model of End Stage Liver Disease) scoring system for assessing the severity of chronic liver disease; calculated from serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) MELD = 3.8\[Ln serum bilirubin (mg/dL)\] + 11.2\[Ln INR\] + 9.6\[Ln serum creatinine (mg/dL)\] + 6.4. MELD score range from 6-40 with higher scores indicating more severe liver disease and a worse outcome.
Outcome measures
| Measure |
Lactobacillus Rhamnosus GG
n=20 Participants
Dietary supplement capsule (Lactobacillus Rhamnosus GG) will be given once daily for 180 days.
Lactobacillus Rhamnosus GG: Probiotic nutritional supplement; Lactobacillus Rhamnosus GG
|
Placebo for Probiotic
n=13 Participants
Placebo capsule that matches the probiotic capsule in appearance will be given once daily for 180 days.
Placebo for Probiotic: Capsule manufactured without active ingredients.
|
|---|---|---|
|
MELD Score
|
14.25 score on a scale
Standard Deviation 3.88
|
14.92 score on a scale
Standard Deviation 6.08
|
SECONDARY outcome
Timeframe: 180 daysPopulation: 14 subjects from the LGG group and 17 subjects from the placebo group were lost to follow up by 180 days
Change in MELD scoring system over 180 day study duration. MELD (Model of End Stage Liver Disease) scoring system for assessing the severity of chronic liver disease; calculated from serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) MELD = 3.8\[Ln serum bilirubin (mg/dL)\] + 11.2\[Ln INR\] + 9.6\[Ln serum creatinine (mg/dL)\] + 6.4. MELD score range from 6-40 with higher scores indicating more severe liver disease and a worse outcome.
Outcome measures
| Measure |
Lactobacillus Rhamnosus GG
n=10 Participants
Dietary supplement capsule (Lactobacillus Rhamnosus GG) will be given once daily for 180 days.
Lactobacillus Rhamnosus GG: Probiotic nutritional supplement; Lactobacillus Rhamnosus GG
|
Placebo for Probiotic
n=4 Participants
Placebo capsule that matches the probiotic capsule in appearance will be given once daily for 180 days.
Placebo for Probiotic: Capsule manufactured without active ingredients.
|
|---|---|---|
|
MELD Score
|
11.0 score on a scale
Standard Deviation 5.46
|
10.50 score on a scale
Standard Deviation 3.11
|
SECONDARY outcome
Timeframe: 90 daysPopulation: 11 subjects from the LGG group and 16 subjects from the placebo group were lost to follow up by 90 days
Change in MELD scoring system at 90 days study duration. MELD (Model of End Stage Liver Disease) scoring system for assessing the severity of chronic liver disease; calculated from serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) MELD = 3.8\[Ln serum bilirubin (mg/dL)\] + 11.2\[Ln INR\] + 9.6\[Ln serum creatinine (mg/dL)\] + 6.4. MELD score range from 6-40 with higher scores indicating more severe liver disease and a worse outcome.
Outcome measures
| Measure |
Lactobacillus Rhamnosus GG
n=13 Participants
Dietary supplement capsule (Lactobacillus Rhamnosus GG) will be given once daily for 180 days.
Lactobacillus Rhamnosus GG: Probiotic nutritional supplement; Lactobacillus Rhamnosus GG
|
Placebo for Probiotic
n=5 Participants
Placebo capsule that matches the probiotic capsule in appearance will be given once daily for 180 days.
Placebo for Probiotic: Capsule manufactured without active ingredients.
|
|---|---|---|
|
MELD Score
|
11.62 score on a scale
Standard Deviation 8.41
|
10.20 score on a scale
Standard Deviation 3.89
|
Adverse Events
Lactobacillus Rhamnosus GG
Serious events: 17 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo for Probiotic
Serious events: 15 serious events
Other events: 15 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Lactobacillus Rhamnosus GG
n=24 participants at risk
Dietary supplement capsule (Lactobacillus Rhamnosus GG) will be given once daily for 180 days.
Lactobacillus Rhamnosus GG: Probiotic nutritional supplement; Lactobacillus Rhamnosus GG
|
Placebo for Probiotic
n=21 participants at risk
Placebo capsule that matches the probiotic capsule in appearance will be given once daily for 180 days.
Placebo for Probiotic: Capsule manufactured without active ingredients.
|
|---|---|---|
|
Cardiac disorders
Ascites
|
0.00%
0/24 • 180 days
|
4.8%
1/21 • 180 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/24 • 180 days
|
4.8%
1/21 • 180 days
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
4.2%
1/24 • 180 days
|
0.00%
0/21 • 180 days
|
|
Infections and infestations
Peritonitis
|
4.2%
1/24 • 180 days
|
0.00%
0/21 • 180 days
|
|
Infections and infestations
Sepsis
|
8.3%
2/24 • 180 days
|
0.00%
0/21 • 180 days
|
|
Metabolism and nutrition disorders
Alcohol intolerance
|
0.00%
0/24 • 180 days
|
14.3%
3/21 • 180 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.2%
1/24 • 180 days
|
0.00%
0/21 • 180 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.2%
1/24 • 180 days
|
9.5%
2/21 • 180 days
|
|
Renal and urinary disorders
Acute kidney injury
|
37.5%
9/24 • 180 days
|
9.5%
2/21 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/24 • 180 days
|
4.8%
1/21 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia bacterial
|
0.00%
0/24 • 180 days
|
4.8%
1/21 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
4.2%
1/24 • 180 days
|
0.00%
0/21 • 180 days
|
|
Vascular disorders
Rectal haemorrhage
|
0.00%
0/24 • 180 days
|
4.8%
1/21 • 180 days
|
|
Vascular disorders
Vaginal haemorrhage
|
4.2%
1/24 • 180 days
|
0.00%
0/21 • 180 days
|
|
General disorders
Multiple conditions defined for single event
|
0.00%
0/24 • 180 days
|
14.3%
3/21 • 180 days
|
Other adverse events
| Measure |
Lactobacillus Rhamnosus GG
n=24 participants at risk
Dietary supplement capsule (Lactobacillus Rhamnosus GG) will be given once daily for 180 days.
Lactobacillus Rhamnosus GG: Probiotic nutritional supplement; Lactobacillus Rhamnosus GG
|
Placebo for Probiotic
n=21 participants at risk
Placebo capsule that matches the probiotic capsule in appearance will be given once daily for 180 days.
Placebo for Probiotic: Capsule manufactured without active ingredients.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/24 • 180 days
|
4.8%
1/21 • 180 days
|
|
Cardiac disorders
Ascites
|
0.00%
0/24 • 180 days
|
14.3%
3/21 • 180 days
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/24 • 180 days
|
4.8%
1/21 • 180 days
|
|
Gastrointestinal disorders
Abdominal pain
|
4.2%
1/24 • 180 days
|
0.00%
0/21 • 180 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/24 • 180 days
|
14.3%
3/21 • 180 days
|
|
Gastrointestinal disorders
Pancreatitis
|
8.3%
2/24 • 180 days
|
0.00%
0/21 • 180 days
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
12.5%
3/24 • 180 days
|
0.00%
0/21 • 180 days
|
|
Investigations
Lipase increased
|
4.2%
1/24 • 180 days
|
0.00%
0/21 • 180 days
|
|
Metabolism and nutrition disorders
Alcohol intolerance
|
0.00%
0/24 • 180 days
|
14.3%
3/21 • 180 days
|
|
Psychiatric disorders
Anxiety
|
4.2%
1/24 • 180 days
|
0.00%
0/21 • 180 days
|
|
Psychiatric disorders
Drug dependence
|
4.2%
1/24 • 180 days
|
0.00%
0/21 • 180 days
|
|
Psychiatric disorders
Insomnia
|
4.2%
1/24 • 180 days
|
0.00%
0/21 • 180 days
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/24 • 180 days
|
4.8%
1/21 • 180 days
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
4.2%
1/24 • 180 days
|
0.00%
0/21 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
1/24 • 180 days
|
0.00%
0/21 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
8.3%
2/24 • 180 days
|
0.00%
0/21 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/24 • 180 days
|
4.8%
1/21 • 180 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.2%
1/24 • 180 days
|
0.00%
0/21 • 180 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/24 • 180 days
|
4.8%
1/21 • 180 days
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
4.2%
1/24 • 180 days
|
0.00%
0/21 • 180 days
|
|
General disorders
Multiple conditions defined for single event
|
0.00%
0/24 • 180 days
|
4.8%
1/21 • 180 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place