Bacteriophage Therapy for Shigellosis

Baltimore, MD

Phase 1 & 2

Waitlist Available

Led By Wilbur Chen Chen, MD, MS

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 day 90

Summary

This trial is testing a new drug to see if it is safe and effective in healthy adults who have been exposed to Shigella.

See full description

Who is the study for?

Healthy adults aged 18-50, with good general health as determined by medical history and tests. Participants must understand the study details, score at least 70% on a comprehension test, have normal blood counts and organ function tests, not be pregnant or breastfeeding, agree to use contraception if applicable, and not participate in other studies concurrently. Excluded are those with certain medical conditions or treatments that could affect safety or results.

What is being tested?

The trial is testing ShigActive™ against a placebo in healthy adults who voluntarily receive an experimental Shigella challenge. It's designed to see if ShigActive™ can safely prevent or treat bacillary dysentery (Shigellosis). The study randomly assigns participants to either the bacteriophage treatment group or the placebo group without them knowing which one they're getting.See study design

What are the potential side effects?

As this is a first-in-human trial for ShigActive™, specific side effects are being studied; however common side effects may include digestive discomforts like stomach pain or diarrhea due to the nature of gastrointestinal interventions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 90

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 90

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 90 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Phase 2a: Number of Solicited and Unsolicited Adverse Reactions

Phase 2a: Onset of Clinical Shigellosis Post-Challenge

Secondary study objectives

Phase 2a: Number of Shigella Organisms Secreted in Stool

Phase 2a: Onset of Moderate-to-Severe Shigellosis Post-Challenge

Phase 2a: Severity of Shigellosis Symptoms

Other study objectives

Phase 1: Effect on Gut Microbiome Community States

Phase 1: Number of Shigella-specific Bacteriophage Shed in Stool

Phase 2a: Geometric Mean Anti-Shigella Antibody Titers

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BacteriophageExperimental Treatment1 Intervention

Dose is 1mL of bacteriophage preparation given orally three times a day for 7 days (Phase 1) or 6 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 6 days (Phase 2a)

Do I qualify?Apply below to find out

Find a Location

Closest Location:University of Maryland, Baltimore, University of Maryland School of Medicine, Center for Vaccine Development and Global Health· Baltimore, MD· 344 miles