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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

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

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

688 Previous Clinical Trials

374,604 Total Patients Enrolled

Wilbur Chen Chen, MD, MSPrincipal InvestigatorUniversity of Maryland, Baltimore, Center for Vaccine Development and Global Health

Media Library

ShigActive™ (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05182749 — Phase 1 & 2

Shigellosis Research Study Groups: Bacteriophage, Placebo

Shigellosis Clinical Trial 2023: ShigActive™ Highlights & Side Effects. Trial Name: NCT05182749 — Phase 1 & 2

ShigActive™ (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05182749 — Phase 1 & 2

Frequently Asked Questions

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

What criteria do participants need to meet in order to qualify for this medical research?

"This medicinal trail is actively recruiting 52 individuals, aged 18 to 50 years old and suffering from shigellosis. Further qualifications include: the patient's willingness to not participate in any other investigational research during their involvement with this study; being able to come into contact with CVD clinical sites throughout the duration of the trial; providing informed consent after understanding all aspects of the study; passing a 70% or higher score on a Comprehension Assessment Tool which covers details discussed before treatment begins; good general health shown through medical history, physical exam, and relevant laboratory tests according to PI judgement; abstaining from donating blood for 30 days post-"

Answered by AI

Does this research accept applicants who are younger than sixty years old?

"According to the requirements of this trial, applicants must be 18 years old or older but cannot exceed 50."

Answered by AI

Are there any opportunities to participate in this experimental investigation currently?

"According to clinicaltrials.gov, the recruitment phase for this study has concluded; it was initially posted on September 1st 2022 and last edited on June 20th 2022. However, 11 other research trials are currently in search of volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy of the Bacteriophage Preparation, ShigActive™, in a Human Experimental Model of Shigellosis

2023. "Safety and Efficacy of the Bacteriophage Preparation, ShigActive™, in a Human Experimental Model of Shigellosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05182749.

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