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Probiotic

VE303 for Encephalopathy

Phase 2

Waitlist Available

Led By Patricia Bloom, MD

Research Sponsored by Patricia Bloom

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 26

Awards & highlights

Study Summary

This trial is testing a new drug to see if it's safe and effective in treating hepatic encephalopathy. If you qualify, you'll take antibiotics followed by the study drug (placebo or VE303) for 14 days. There will be tests and other procedures to collect data and monitor your cognition.

Eligible Conditions

Liver Encephalopathy
Liver Cirrhosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 26

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 26

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 26 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Psychometric Hepatic Encephalopathy Score (PHES) as a measure of cognitive function from pre-vancomycin to week 6

Number of serious adverse events up to week 6

Secondary outcome measures

Adverse events up to week 26

Change in Patient Reported Outcome Measurement Information System (PROMIS) Global Health reported from pre-vancomycin to week 26

Change in microbiome composition from pre-vancomycin to week 26

+4 more

Side effects data

From 2021 Phase 2 trial • 79 Patients • NCT03788434

72%

Diarrhea

21%

Nausea

17%

Abdominal Pain

10%

Constipation

Flatulence

Abdominal Distension

Headache

Fatigue

Dysgeusia

Irritable Bowel Syndrome

Abdominal Pain Upper

Chills

Blood Potassium Increased

Vomiting

Dyspepsia

Transfusion Reaction

Cough

Urinary Tract Infection

Dehydration

100%

80%

60%

40%

20%

Study treatment Arm

VE303 High Dose

VE303 Low Dose

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: VE303Experimental Treatment2 Interventions

VE303 is a live biotherapeutic product comprising 8 nonpathogenic commensal strains of Clostridia.

Group II: PlaceboPlacebo Group2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VE303

2019

Completed Phase 2

~120

Vancomycin

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Patricia BloomLead Sponsor

Vedanta Biosciences, Inc.Industry Sponsor

6 Previous Clinical Trials

1,186 Total Patients Enrolled

American College of GastroenterologyOTHER

37 Previous Clinical Trials

6,925 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What safety considerations must be taken when administering VE303?

"The safety of VE303 was graded a 2 due to the fact that, at this stage in its development, there is only data confirming it's relative security and not any evidence backing up its efficacy."

Answered by AI

Are there still vacancies for participants in this experiment?

"Affirmative, clinicaltrials.gov hosts information suggesting that recruitment for this trial is ongoing. It was initially posted on August 6th 2021 and last updated on August 1st 2022. 18 participants are needed between one medical facility."

Answered by AI

Who is eligible to join this clinical investigation?

"This clinical trial seeks to enroll 18 individuals between the ages of eighteen and seventy-five who have suffered from hepatic coma in their past. Critically, applicants must demonstrate a history of overt HE at some point prior."

Answered by AI

What is the common purpose of VE303 treatments?

"Infections caused by the staphylococcus bacteria, including staphylococcal infections and enterocolitis due to Staphylococcus aureus strains, can be managed through VE303."

Answered by AI

Is the eligibility for this trial limited to persons under eighty years of age?

"This experiment is seeking out individuals who are within the age range of 18 to 75."

Answered by AI

What is the current capacity for participants in this trial?

"Affirmative. Clinicaltrials.gov records elucidate that this medical trial, first posted on August 6th 2021 and last updated on August 1st 2022, is currently seeking participants. A total of 18 patients have to be recruited from one location for the study to begin."

Answered by AI

Are there any other explorations that have been conducted using VE303?

"Presently, 6 trials for VE303 have transgressed to Phase 3 with a total of 55 active clinical studies. There are 315 sites hosting these medical trials, and some can be found in Jupiter, Florida."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

VE303 for Treatment of Hepatic Encephalopathy (HE)

Patricia Bloom 2021. "VE303 for Treatment of Hepatic Encephalopathy (HE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04899115.

All > Hepatic Encephalopathy