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Oral Phage Therapy for Enterococcus Colonization

Phase 1 & 2

Recruiting

Led By Minh-Hong Nguyen, MD

Research Sponsored by Intralytix, Inc.

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 180 days

Awards & highlights

Study Summary

This trial tests a new drug to fight infection in adults with a specific type of bacteria. It'll assess safety & effectiveness.

Who is the study for?

This trial is for healthy adults aged 18-50 with a BMI of 19-40 kg/m2, who are not pregnant, do not have HIV or hepatitis, and agree to avoid other clinical studies. Participants must understand the study and follow its schedule. They should be in good health as determined by medical history and screening tests.Check my eligibility

What is being tested?

The trial is testing VRELysin™ against a placebo in a randomized, double-blind setup to see if it's safe and effective for people colonized by Enterococcus bacteria. It's the first time this treatment is being tried on humans.See study design

What are the potential side effects?

Since this is a Phase 1/2a trial primarily designed to assess safety, specific side effects of VRELysin™ are not yet known but will be closely monitored throughout the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 180 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 180 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 180 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Phase 1: Number and Severity of Solicited and Unsolicited Adverse Reactions

Phase 2a: Number and Severity of Solicited and Unsolicited Adverse Reactions

Secondary outcome measures

Phase 2a: Change in Number of VRE Organisms Secreted in Stool

Phase 2a: Decolonization of VRE in Stool at Day 15

Phase 2a: Number of VRE Organisms Secreted in Stool at Day 15

+2 more

Other outcome measures

Phase 1: Effect on Gut Microbiome Community States

Phase 1: Number of VRE-specific Bacteriophage Shed in Blood and Stool

Phase 2a: Effect on Gut Microbiome Community States

+1 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: VRELysin™Active Control1 Intervention

Dose is 1mL of bacteriophage preparation given orally three times a day for 7 days (Phase 1) or 14 days (Phase 2a)

Group II: PlaceboPlacebo Group1 Intervention

Dose is 1mL of placebo given orally three times a day for 7 days (Phase 1) or 14 days (Phase 2a)

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Intralytix, Inc.Lead Sponsor

2 Previous Clinical Trials

82 Total Patients Enrolled

Minh-Hong Nguyen, MDPrincipal InvestigatorUniversity of Pittsburgh

Frequently Asked Questions

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

Is the patient eligibility range for this clinical trial inclusive of those over 70 years old?

"In accordance with the trial's regulations, the minimum age for participation is 18 while the maximum age of subjects must be 50."

Answered by AI

Has enrollment for this trial been closed, or are there still opportunities to participate?

"That is correct. Per the clinicaltrials.gov portal, this trial has been recruiting patients since October 25th 2021 and was last modified a day later. A total of 80 subjects are being sought from 1 medical centre."

Answered by AI

To what extent is patient participation being sought in this experiment?

"Indeed. According to the information available on clinicaltrials.gov, this particular trial is actively recruiting participants as of October 26th 2023; its listing was first posted back on October 25th 2023. The study is looking for a total of 80 volunteers from one single location."

Answered by AI

What is the prime goal of this clinical experiment?

"This clinical trial, running for up to 36 days, is primarily designed to measure the number and severity of adverse reactions. Secondary objectives include assessing the prevalence of VRE shedding in stool samples at day 15 following treatment with either VRELysin or placebo, ascertaining whether decolonization has occurred by Day 15, as well as evaluating VRE presence in stool samples on Day 29 after intervention."

Answered by AI

Do I meet the qualifications to participate in this experimental research?

"This clinical trial is recruiting 80 participants aged 18 to 50 with enterococcus colonization. To be eligible, candidates must meet the qualifications outlined: Age within range of 18-50 years old., BMI between 19 and 40kg/m2, Capability to understand study risks and procedures., Willingness to give written informed consent., No other investigational treatments (excluding life saving or COVID-19 related)., Good general health as determined by medical history etc.. , Negative HIV, HBsAg & HCV antibody tests., For female applicants; negative serum or urine β-HCG test at Screening + 24 hours prior to initial"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy of Oral Administration of the Phage Cocktail, VRELysin™, In Healthy and VRE-Colonized Subjects

2023. "Safety and Efficacy of Oral Administration of the Phage Cocktail, VRELysin™, In Healthy and VRE-Colonized Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05715619.