Bacteriophage Therapy for Shigellosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety and effectiveness of ShigActive, a new treatment for Shigellosis, an infection caused by Shigella bacteria that can lead to severe diarrhea. Participants will receive either the experimental treatment, a bacteriophage preparation (viruses that infect bacteria), or a placebo for comparison. This trial is suitable for healthy adults who have not had shigellosis in the past three years and are willing to engage in a detailed study process. As a Phase 1 and Phase 2 trial, participants will be among the first to receive this new treatment and help assess its effectiveness in a smaller group.
Will I have to stop taking my current medications?
The trial requires that you stop using certain medications, such as antidiarrheals, stool softeners, laxatives, antacids, oral or IV antimicrobials, proton pump inhibitors, H2 blockers, and supplemental probiotics before and during the study. If you are taking any of these, you may need to stop them to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that ShigActive, a treatment for Shigella infections, is safe and easy to use. In a previous study, participants took ShigActive without experiencing major safety issues, suggesting that the treatment is generally safe for humans. Participants did not report any serious side effects.
Overall, the evidence so far is promising for ShigActive’s safety in treating Shigella.12345Why do researchers think this study treatment might be promising for Shigellosis?
Unlike the standard treatments for shigellosis, which typically involve antibiotics, ShigActive™ uses bacteriophages—viruses that specifically target and kill bacteria. This unique mechanism of action allows it to directly attack the Shigella bacteria without harming the beneficial bacteria in your gut. Researchers are excited because bacteriophage therapy could offer a solution to antibiotic resistance, a growing problem with current treatment options, and may result in fewer side effects.
What evidence suggests that ShigActive™ might be an effective treatment for Shigellosis?
Research has shown that ShigActive™, a treatment using special viruses called bacteriophages, may help fight Shigella infections. In this trial, participants will receive either ShigActive™ or a placebo. Studies have found that this therapy can reduce the number of Shigella bacteria, potentially aiding in the treatment of these infections. Earlier studies demonstrated that ShigActive is safe and well-tolerated by people. Evidence indicates that using a combination of these viruses can effectively treat infections caused by Shigella and similar bacteria. These findings suggest that ShigActive could be a promising treatment for shigellosis.34567
Who Is on the Research Team?
Wilbur Chen Chen, MD, MS
Principal Investigator
University of Maryland, Baltimore, Center for Vaccine Development and Global Health
Alexander Sulakvelidze, PhD
Principal Investigator
Intralytix, Inc.
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1 Treatment
Participants receive 1mL of bacteriophage preparation or placebo orally three times a day for 7 days to assess safety
Phase 2a Treatment
Participants receive 1mL of bacteriophage preparation or placebo orally three times a day for 6 days, followed by a challenge with Shigella to assess safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adverse events and immune response
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- ShigActive™
Trial Overview
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Dose is 1mL of bacteriophage preparation given orally three times a day for 7 days (Phase 1) or 6 days (Phase 2a)
Dose is 1mL of placebo given orally three times a day for 7 days (Phase 1) or 6 days (Phase 2a)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Intralytix, Inc.
Lead Sponsor
University of Maryland, Baltimore
Collaborator
Citations
Safety and Tolerability of ShigActive™, a Shigella spp. ...
The results of this first-in-human (FIH) randomized, controlled Phase 1 trial of ShigActive™ demonstrate that it is safe and well tolerated when ...
Study Details | NCT05182749 | Safety and Efficacy of the ...
The purpose of this study is to determine if ShigActive is safe and effective in healthy adults in a continuous Phase 1/2a trial. Phase 1 will asses the ...
Therapeutic potential of Shigella phage SSG23 against ...
The correlation between decreased Shigella CFU and higher phage titers demonstrates that phage therapy is effective in decreasing infection.
Utilizing the effectiveness of phage cocktail to combat Shigella ...
Our findings demonstrate that Shigella-Salmonella infections could be effectively treated with phage cocktails that include the recently ...
Safety and Efficacy of the Bacteriophage Preparation ...
The study is a first-in-human Phase 1/2a randomized, double-blind, placebo-controlled trial to assess the clinical safety and efficacy of ...
Safety and Tolerability of ShigActive™, a Shigella spp ...
The results of this first-in-human (FIH) randomized, controlled Phase 1 trial of ShigActive™ demonstrate that it is safe and well tolerated when ...
Safety and Tolerability of ShigActive™, a Shigella spp. ...
The results of this first-in-human (FIH) randomized, controlled Phase 1 trial of ShigActive™ demonstrate that it is safe and well tolerated when ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.