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Virus Therapy
Bacteriophage Therapy for Shigellosis
Phase 1 & 2
Recruiting
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
Awards & highlights
Study 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.
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.Check my eligibility
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
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 of Solicited and Unsolicited Adverse Reactions
Phase 2a: Onset of Clinical Shigellosis Post-Challenge
Secondary outcome measures
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 outcome measures
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 moreTrial 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)
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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
110 Total Patients Enrolled
University of Maryland, BaltimoreOTHER
692 Previous Clinical Trials
376,812 Total Patients Enrolled
Wilbur Chen Chen, MD, MSPrincipal InvestigatorUniversity of Maryland, Baltimore, Center for Vaccine Development and Global Health
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a bleeding disorder.I am between 18 and 50 years old.I have not received any blood products in the last 4 months.I do not have a spleen.I have abnormal bowel movements.I can stay in the hospital for 12 days, am fully vaccinated against COVID-19, and can complete a pre-study visit.I have been diagnosed with cancer.I have not taken certain medications recently.I agree not to donate blood while in the study and for 30 days after.I have a long-term stomach or intestine illness.I have epilepsy or a seizure disorder.I have difficulty with blood draws or IV access.I am willing to join the trial after understanding all its aspects.I regularly use prescribed medications.
Research Study Groups:
This trial has the following groups:- Group 1: Bacteriophage
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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