A Phase 2 interventional study of Placebo and VE303 in Cirrhosis and Hepatic Encephalopathy, sponsored by Patricia Bloom. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-07.
Sponsored by Patricia Bloom · Phase 2, Interventional, and Treatment
This research is studying the use of a new drug to learn about its safety and efficacy as a treatment for hepatic encephalopathy.
Eligible participants will be enrolled and given oral antibiotics followed by 14 days of the study drug (placebo vs.VE303). There will be visits as well as other procedures to collect blood and stool samples, and have tests of your cognition (thinking) for this research study.
The hypothesis is that VE303 will safely and effectively improve cognitive function in patients with a history of overt hepatic encephalopathy.
3,274 studies on the registry are indexed under Fibrosis; 466 are open to participants now.
This study's enrollment of 19 is below the median of 50 across 2,137 interventional studies indexed under Fibrosis.
Browse Fibrosis studies →This is the only study on the registry with Patricia Bloom as lead sponsor.
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Exclusion Criteria:
Drug: Placebo · Drug: oral vancomycin
VE303 is a live biotherapeutic product comprising 8 nonpathogenic commensal strains of Clostridia.
Drug: VE303 · Drug: oral vancomycin
Starting the last day of oral vancomycin (Day 1), subjects randomized to this arm will take 5 capsules of placebo for 14 days taken once daily.
Starting the last day of oral vancomycin (Day 1), subjects randomized to this arm will take 5 capsules of VE303 taken daily for 14 days. The quantity of each strain is proportioned to assure a specific per-strain per-capsule titer. The 8 strains are blended together with a micro-crystalline cellulose flow agent and placed in enteric capsules.
All enrolled subjects will receive 5 days of oral vancomycin 125 mg four times a day (q.i.d).
Number of Participants Who Experienced Serious Adverse Events up to Week 6
An adverse event (AE) or suspected adverse reaction is considered "serious" if, in the view of the investigator, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Time frame: Week 6
Change in Psychometric Hepatic Encephalopathy Score (PHES) as a Measure of Cognitive Function From Pre-vancomycin to Week 6
This score is a battery of 5 paper-pencil tests that evaluate cognitive and psychomotor processing speed and visuomotor coordination. Scores on each subtest are assigned values based on age-related norms (1+ for scores better than 1 standard deviation (SD) above the normal mean to -3 for scores more than 3 SDs below the normal mean). Combined scores vary from +6 to -18, where +6 is the best function and -18 is worst function.
Time frame: baseline (pre-vancomycin), Week 6
Number of Hospitalizations for Overt Hepatic Encephalopathy (OHE) up to Week 26
Shown as a rate (# of episodes/ number of patients) = # per patient.
Time frame: 26 weeks
Adverse Events up to Week 26
total number of AEs
Time frame: up to week 26
Change in Patient Reported Outcome Measurement Information System (PROMIS) Global Health Reported From Pre-vancomycin to Week 26
The PROMIS v 1.1 is a 10 question scale where participants select answers from (0) up to (10). Higher scores indicate better quality of life. Results are presented as change in scores pertaining to physical and mental health.
Time frame: baseline (pre-vancomycin), week 26
Time to Overt HE
This is the number of days from Day 1 of Vancomycin to the first OHE event or to the end of study, whichever came first.
Time frame: up to 26 weeks
Change in Microbiome Composition From Pre-vancomycin to Week 26
This will be calculated by alpha diversity between stool collection timepoints and will have metagenomic sequencing on stool to assess this. The Shannon index is a calculation used to measure the diversity of microbial species within a sample, taking into account both the number of different species present (richness) and how evenly distributed their abundances are (evenness). A higher Shannon index indicates a more diverse microbial community, meaning a wider variety of microbes present in roughly equal proportions. The Shannon index was calculated for each sample as part of metagenomic sequencing analysis performed with the tool MetaPhlAn (version 3.0). The minimum Shannon index value is 0 and it could theoretically go to infinity; however, typical values range more in the 1-4 range. Now, this outcome is measuring the CHANGE in Shannon index, therefore negative values are possible, if the diversity of specimens dropped from the pre-vancomycin to the week 26 samples.
Time frame: baseline (pre-vancomycin), week 26
PHES From Pre-vancomycin to Week 26
This score is a battery of 5 paper-pencil tests that evaluate cognitive and psychomotor processing speed and visuomotor coordination. Scores on each subtest are assigned values based on age-related norms (+1 for scores better than 1 standard deviation (SD) above the normal mean to -3 for scores more than 3 SDs below the normal mean). Combined scores vary from +6 to -18.
Time frame: pre-vancomycin up to week 26
Change in Serum and Stool Biomarkers From Pre-vancomycin to Week 26
Time frame: baseline (pre-vancomycin), week 26
| Milestone | Placebo | VE303 |
|---|---|---|
| Started | 6 | 12 |
| Completed | 6 | 12 |
| Not completed | 0 | 0 |
An adverse event (AE) or suspected adverse reaction is considered "serious" if, in the view of the investigator, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
| Participants | VE303 | Placebo |
|---|---|---|
| Number of Participants Who Experienced Serious Adverse Events up to Week 6 | 2 | 0 |
This score is a battery of 5 paper-pencil tests that evaluate cognitive and psychomotor processing speed and visuomotor coordination. Scores on each subtest are assigned values based on age-related norms (1+ for scores better than 1 standard deviation (SD) above the normal mean to -3 for scores more than 3 SDs below the normal mean). Combined scores vary from +6 to -18, where +6 is the best function and -18 is worst function.
| units on a scale | Placebo | VE303 |
|---|---|---|
| Change in Psychometric Hepatic Encephalopathy Score (PHES) as a Measure of Cognitive Function From Pre-vancomycin to Week 6 | -1.0 ± 3.7 | 1.5 ± 3.5 |
Shown as a rate (# of episodes/ number of patients) = # per patient.
| episodes/patient | Placebo | VE303 |
|---|---|---|
| Number of Hospitalizations for Overt Hepatic Encephalopathy (OHE) up to Week 26 | .333 (0 to 2) | 1.25 (0 to 6) |
total number of AEs
| adverse events | Placebo | VE303 |
|---|---|---|
| Adverse Events up to Week 26 | 38 | 135 |
The PROMIS v 1.1 is a 10 question scale where participants select answers from (0) up to (10). Higher scores indicate better quality of life. Results are presented as change in scores pertaining to physical and mental health.
| score on a scale | Placebo | VE303 |
|---|---|---|
| Change in PROMIS Physical Health Scores | 1.8 ± 1.8 | 0.4 ± 1.9 |
| Change in PROMIS Mental Health Scores | 1.2 ± 2.1 | 0 ± 2.4 |
This is the number of days from Day 1 of Vancomycin to the first OHE event or to the end of study, whichever came first.
| days | Placebo | VE303 |
|---|---|---|
| Time to Overt HE | 180 (170 to 182) | 147 (16 to 182) |
This will be calculated by alpha diversity between stool collection timepoints and will have metagenomic sequencing on stool to assess this. The Shannon index is a calculation used to measure the diversity of microbial species within a sample, taking into account both the number of different species present (richness) and how evenly distributed their abundances are (evenness). A higher Shannon index indicates a more diverse microbial community, meaning a wider variety of microbes present in roughly equal proportions. The Shannon index was calculated for each sample as part of metagenomic sequencing analysis performed with the tool MetaPhlAn (version 3.0). The minimum Shannon index value is 0 and it could theoretically go to infinity; however, typical values range more in the 1-4 range. Now, this outcome is measuring the CHANGE in Shannon index, therefore negative values are possible, if the diversity of specimens dropped from the pre-vancomycin to the week 26 samples.
| Shannon index | VE303 | Placebo |
|---|---|---|
| Change in Microbiome Composition From Pre-vancomycin to Week 26 | 0.37 ± 0.72 | -0.15 ± 0.06 |
This score is a battery of 5 paper-pencil tests that evaluate cognitive and psychomotor processing speed and visuomotor coordination. Scores on each subtest are assigned values based on age-related norms (+1 for scores better than 1 standard deviation (SD) above the normal mean to -3 for scores more than 3 SDs below the normal mean). Combined scores vary from +6 to -18.
| score on a scale | Placebo | VE303 |
|---|---|---|
| PHES From Pre-vancomycin to Week 26 | -1 (-3 to 1) | 1 (-6 to 10) |
Results for this outcome have not been posted.
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/6 (0%) | 1/6 (16.7%) | 6/6 (100%) |
| VE303 | 0/12 (0%) | 5/12 (41.7%) | 12/12 (100%) |
| Event | Placebo | VE303 |
|---|---|---|
| Hospitalized for Hepatic EncephalopathyHepatobiliary disorders | 1/6 | 4/12 |
| Pain and Bleeding from Surgical SiteInjury, poisoning and procedural complications | 1/6 | 0/12 |
| Wound DehiscenceInjury, poisoning and procedural complications | 1/6 | 0/12 |
| Hospitalization due to Esophageal BleedGastrointestinal disorders | 1/6 | 0/12 |
| Inpatient Catheter ServiceSurgical and medical procedures | 0/6 | 1/12 |
| Hyperglycemic Hyperosmolar SyndromeMetabolism and nutrition disorders | 0/6 | 1/12 |
| Hospitalization due to Ascites AccumulationHepatobiliary disorders | 0/6 | 1/12 |
| Abdominal PainGastrointestinal disorders | 0/6 | 1/12 |
| Hospitalization for Diabetic KetoacidosisMetabolism and nutrition disorders | 0/6 | 1/12 |
| Elective Total Hip ReplacementSurgical and medical procedures | 0/6 | 1/12 |
| Event | Placebo | VE303 |
|---|---|---|
| DiarrheaGastrointestinal disorders | 2/6 | 8/12 |
| Abdominal DistensionGastrointestinal disorders | 0/6 | 7/12 |
| Abdominal PainGastrointestinal disorders | 1/6 | 7/12 |
| Decreased Lymphocyte CountBlood and lymphatic system disorders | 1/6 | 7/12 |
| NauseaGastrointestinal disorders | 1/6 | 7/12 |
| Decreased Platelet CountBlood and lymphatic system disorders | 3/6 | 3/12 |
| Increased Bowel MovementsGastrointestinal disorders | 1/6 | 5/12 |
| Alkaline Phosphatase IncreaseHepatobiliary disorders | 2/6 | 3/12 |
| Alanine Transaminase IncreaseHepatobiliary disorders | 2/6 | 0/12 |
| Increased LipaseGastrointestinal disorders | 2/6 | 4/12 |
| Age, Continuous(years) | Placebo | VE303 | Total |
|---|---|---|---|
| Mean | 63 ± 7 | 58 ± 10 | 60 ± 9 |
| Sex: Female, Male(Participants) | Placebo | VE303 | Total |
|---|---|---|---|
| Female | 2 | 6 | 8 |
| Male | 4 | 6 | 10 |
| Race/Ethnicity, Customized(Participants) | Placebo | VE303 | Total |
|---|---|---|---|
| Black or African American | 1 | 1 | 2 |
| White | 4 | 10 | 14 |
| Other | 1 | 1 | 2 |
| Region of Enrollment(Participants) | Placebo | VE303 | Total |
|---|---|---|---|
| United States | 6 | 12 | 18 |
| Baseline Psychometric HE Score (PHES)(units on a scale) | Placebo | VE303 | Total |
|---|---|---|---|
| Mean | -5.0 ± 3.7 | -6.3 ± 3.4 | -5.8 ± 3.5 |
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Studies of the drug tested here: Clostridia Strain Formulation VE303