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Novel Therapies in Moderately Severe Acute Alcoholic Hepatitis (NTAH-Mod)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01922895
Recruitment Status : Terminated (Lack of funding)
First Posted : August 14, 2013
Results First Posted : March 2, 2022
Last Update Posted : March 2, 2022
Sponsor:
Collaborators:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
The Cleveland Clinic
University of Massachusetts, Worcester
University of Louisville
Information provided by (Responsible Party):
Mack Mitchell, University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Other
Condition Acute Alcoholic Hepatitis
Interventions Dietary Supplement: Lactobacillus Rhamnosus GG
Drug: Placebo for Probiotic
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lactobacillus Rhamnosus GG Placebo for Probiotic
Hide Arm/Group Description

Dietary supplement capsule (Lactobacillus Rhamnosus GG) will be given once daily for 180 days.

Lactobacillus Rhamnosus GG: Probiotic nutritional supplement; Lactobacillus Rhamnosus GG

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.

Period Title: Overall Study
Started 24 21
Completed 18 7
Not Completed 6 14
Reason Not Completed
Death             0             1
Withdrawal by Subject             1             2
Lost to Follow-up             5             11
Arm/Group Title Lactobacillus Rhamnosus GG Placebo for Probiotic Total
Hide Arm/Group Description

Dietary supplement capsule (Lactobacillus Rhamnosus GG) will be given once daily for 180 days.

Lactobacillus Rhamnosus GG: Probiotic nutritional supplement; Lactobacillus Rhamnosus GG

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 of all reporting groups
Overall Number of Baseline Participants 24 21 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 21 participants 45 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
24
 100.0%
21
 100.0%
45
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 21 participants 45 participants
44.2  (12.0) 45.0  (9.4) 44.6  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 21 participants 45 participants
Female
9
  37.5%
11
  52.4%
20
  44.4%
Male
15
  62.5%
10
  47.6%
25
  55.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 21 participants 45 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   4.8%
1
   2.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   4.2%
2
   9.5%
3
   6.7%
White
23
  95.8%
18
  85.7%
41
  91.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants 21 participants 45 participants
24 21 45
1.Primary Outcome
Title MELD Score
Hide Description 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.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Four subjects from the LGG group and 8 subjects from the placebo group were lost to follow-up.
Arm/Group Title Lactobacillus Rhamnosus GG Placebo for Probiotic
Hide Arm/Group Description:

Dietary supplement capsule (Lactobacillus Rhamnosus GG) will be given once daily for 180 days.

Lactobacillus Rhamnosus GG: Probiotic nutritional supplement; Lactobacillus Rhamnosus GG

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 Number of Participants Analyzed 20 13
Mean (Standard Deviation)
Unit of Measure: score on a scale
14.25  (3.88) 14.92  (6.08)
2.Secondary Outcome
Title MELD Score
Hide Description 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.
Time Frame 180 days
Hide Outcome Measure Data
Hide Analysis Population Description
14 subjects from the LGG group and 17 subjects from the placebo group were lost to follow up by 180 days
Arm/Group Title Lactobacillus Rhamnosus GG Placebo for Probiotic
Hide Arm/Group Description:

Dietary supplement capsule (Lactobacillus Rhamnosus GG) will be given once daily for 180 days.

Lactobacillus Rhamnosus GG: Probiotic nutritional supplement; Lactobacillus Rhamnosus GG

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 Number of Participants Analyzed 10 4
Mean (Standard Deviation)
Unit of Measure: score on a scale
11.0  (5.46) 10.50  (3.11)
3.Secondary Outcome
Title MELD Score
Hide Description 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.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
11 subjects from the LGG group and 16 subjects from the placebo group were lost to follow up by 90 days
Arm/Group Title Lactobacillus Rhamnosus GG Placebo for Probiotic
Hide Arm/Group Description:

Dietary supplement capsule (Lactobacillus Rhamnosus GG) will be given once daily for 180 days.

Lactobacillus Rhamnosus GG: Probiotic nutritional supplement; Lactobacillus Rhamnosus GG

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 Number of Participants Analyzed 13 5
Mean (Standard Deviation)
Unit of Measure: score on a scale
11.62  (8.41) 10.20  (3.89)
Time Frame 180 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lactobacillus Rhamnosus GG Placebo for Probiotic
Hide Arm/Group Description

Dietary supplement capsule (Lactobacillus Rhamnosus GG) will be given once daily for 180 days.

Lactobacillus Rhamnosus GG: Probiotic nutritional supplement; Lactobacillus Rhamnosus GG

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.

All-Cause Mortality
Lactobacillus Rhamnosus GG Placebo for Probiotic
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   1/21 (4.76%) 
Hide Serious Adverse Events
Lactobacillus Rhamnosus GG Placebo for Probiotic
Affected / at Risk (%) Affected / at Risk (%)
Total   17/24 (70.83%)   15/21 (71.43%) 
Cardiac disorders     
Ascites  1  0/24 (0.00%)  1/21 (4.76%) 
Gastrointestinal disorders     
Vomiting  1  0/24 (0.00%)  1/21 (4.76%) 
General disorders     
Multiple conditions defined for single event  1  0/24 (0.00%)  3/21 (14.29%) 
Hepatobiliary disorders     
Hepatitis alcoholic  1  1/24 (4.17%)  0/21 (0.00%) 
Infections and infestations     
Peritonitis  1  1/24 (4.17%)  0/21 (0.00%) 
Sepsis  1  2/24 (8.33%)  0/21 (0.00%) 
Metabolism and nutrition disorders     
Alcohol intolerance  1  0/24 (0.00%)  3/21 (14.29%) 
Hyperglycaemia  1  1/24 (4.17%)  0/21 (0.00%) 
Hyponatraemia  1  1/24 (4.17%)  2/21 (9.52%) 
Renal and urinary disorders     
Acute kidney injury  1  9/24 (37.50%)  2/21 (9.52%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonia  1  0/24 (0.00%)  1/21 (4.76%) 
Pneumonia bacterial  1  0/24 (0.00%)  1/21 (4.76%) 
Upper respiratory tract infection  1  1/24 (4.17%)  0/21 (0.00%) 
Vascular disorders     
Rectal haemorrhage  1  0/24 (0.00%)  1/21 (4.76%) 
Vaginal haemorrhage  1  1/24 (4.17%)  0/21 (0.00%) 
1
Term from vocabulary, MedDRA Version 20.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lactobacillus Rhamnosus GG Placebo for Probiotic
Affected / at Risk (%) Affected / at Risk (%)
Total   16/24 (66.67%)   15/21 (71.43%) 
Blood and lymphatic system disorders     
Anaemia  1  0/24 (0.00%)  1/21 (4.76%) 
Cardiac disorders     
Ascites  1  0/24 (0.00%)  3/21 (14.29%) 
Gastrointestinal disorders     
Abdominal distension  1  0/24 (0.00%)  1/21 (4.76%) 
Abdominal pain  1  1/24 (4.17%)  0/21 (0.00%) 
Diarrhoea  1  0/24 (0.00%)  3/21 (14.29%) 
Pancreatitis  1  2/24 (8.33%)  0/21 (0.00%) 
General disorders     
Multiple conditions defined for single event  1  0/24 (0.00%)  1/21 (4.76%) 
Injury, poisoning and procedural complications     
Alcohol poisoning  1  3/24 (12.50%)  0/21 (0.00%) 
Investigations     
Lipase increased  1  1/24 (4.17%)  0/21 (0.00%) 
Metabolism and nutrition disorders     
Alcohol intolerance  1  0/24 (0.00%)  3/21 (14.29%) 
Psychiatric disorders     
Anxiety  1  1/24 (4.17%)  0/21 (0.00%) 
Drug dependence  1  1/24 (4.17%)  0/21 (0.00%) 
Insomnia  1  1/24 (4.17%)  0/21 (0.00%) 
Renal and urinary disorders     
Urinary tract infection  1  0/24 (0.00%)  1/21 (4.76%) 
Reproductive system and breast disorders     
Erectile dysfunction  1  1/24 (4.17%)  0/21 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/24 (4.17%)  0/21 (0.00%) 
Lung infection  1  2/24 (8.33%)  0/21 (0.00%) 
Pleural effusion  1  0/24 (0.00%)  1/21 (4.76%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  1/24 (4.17%)  0/21 (0.00%) 
Rash  1  0/24 (0.00%)  1/21 (4.76%) 
Skin infection  1  1/24 (4.17%)  0/21 (0.00%) 
1
Term from vocabulary, MedDRA Version 20.1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mack C. Mitchell, MD
Organization: U.T. Southwestern Medical Center
Phone: 2146485036
EMail: mack.mitchell@utsouthwestern.edu
Layout table for additonal information
Responsible Party: Mack Mitchell, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01922895    
Other Study ID Numbers: STU 092012-012
U01AA021893-01 ( U.S. NIH Grant/Contract )
First Submitted: August 12, 2013
First Posted: August 14, 2013
Results First Submitted: January 9, 2022
Results First Posted: March 2, 2022
Last Update Posted: March 2, 2022