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| Name | Class |
|---|---|
| Bausch Health Americas, Inc. | INDUSTRY |
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The purpose of this study is to determine whether alteration of gut flora with rifaximin can lead to improvement in driving performance, psychometric test performance, and quality of life in patients with minimal hepatic encephalopathy (MHE) and cirrhosis in a randomized, blinded, placebo-controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Will be given placebo and follow the exact procedures as the experimental section |
|
| Drug | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifaximin | Drug | 550mg BID rifaximin for 8 weeks |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Driving Performance | Total driving errors at the end of drug/placebo. Minimum is zero, maximum is not defined. Higher number indicates greater errors. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Psychometric Test Performance | Z score of combined cognitive tests at end of rifaximin/placebo; higher scores indicate better psychometric test performance | 8 weeks |
| Total Sickness Impact Profile Score |
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Inclusion Criteria:
Exclusion Criteria:
Current or recent (< 6 month) use of alcohol (AUDIT questionnaire will be used; any cirrhotic with a value of > 0 will be excluded) and a positive blood alcohol level
Use of antibiotics within last 6 weeks
Allergy to rifaximin, rifabutin, rifampin, or rifapentine
Infection or gastrointestinal hemorrhage within the last 6 weeks
Renal insufficiency
Hepatocellular carcinoma
Psychoactive drug use, including interferon concurrently
Non-drivers and those who drive less than 20 miles/week
Pregnancy and breastfeeding
Excluding patients with OHE:
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| Name | Affiliation | Role |
|---|---|---|
| Jasmohan S Bajaj, MBBS, MD, MS | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunter Holmes McGuire VA Medical Center | Richmond | Virginia | 23249 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20849805 | Result | Bajaj JS, Heuman DM, Wade JB, Gibson DP, Saeian K, Wegelin JA, Hafeezullah M, Bell DE, Sterling RK, Stravitz RT, Fuchs M, Luketic V, Sanyal AJ. Rifaximin improves driving simulator performance in a randomized trial of patients with minimal hepatic encephalopathy. Gastroenterology. 2011 Feb;140(2):478-487.e1. doi: 10.1053/j.gastro.2010.08.061. Epub 2010 Sep 21. | |
| 37467180 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Will be given placebo and follow the exact procedures as the experimental section placebo: same as the experimental arm |
| FG001 | Rifaximin | Rifaximin: 550mg BID rifaximin for 8 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Will be given placebo and follow the exact procedures as the experimental section placebo: same as the experimental arm |
| BG001 | Rifaximin | Rifaximin: 550mg BID rifaximin 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, Categorical | Count of Participants |
| 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 | Driving Performance | Total driving errors at the end of drug/placebo. Minimum is zero, maximum is not defined. Higher number indicates greater errors. | Posted | Mean | Standard Deviation | raw number of driving errors | 8 weeks |
|
|
8 weels
Same as the ones in www.clinicaltrials.gov definitions
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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 | Placebo | Will be given placebo and follow the exact procedures as the experimental section placebo: same as the experimental arm |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jasmohan Bajaj | Hunter Holmes McGuire VAMC | 804 675 5802 | jasmohan@gmail.com |
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| ID | Term |
|---|---|
| D006501 | Hepatic Encephalopathy |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000078262 | Rifaximin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
same as the experimental arm |
|
Total score ranging from 0 through >100 at the end of drug/placebo. Higher score indicates worse QOL
| 8 weeks |
| Zacharias HD, Kamel F, Tan J, Kimer N, Gluud LL, Morgan MY. Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD011585. doi: 10.1002/14651858.CD011585.pub2. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Psychometric Test Performance | Z score of combined cognitive tests at end of rifaximin/placebo; higher scores indicate better psychometric test performance | Posted | Mean | Standard Deviation | Z scores | 8 weeks |
|
|
|
| Secondary | Total Sickness Impact Profile Score | Total score ranging from 0 through >100 at the end of drug/placebo. Higher score indicates worse QOL | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Rifaximin | Rifaximin: 550mg BID rifaximin for 8 weeks | 0 | 21 | 0 | 21 | 0 | 21 |
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| D001928 |
| Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |