Bacteriophage Therapy for Shigellosis

Overseen By Wilbur Chen, MD, MS

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Intralytix, Inc.

Must not be taking: Antidiarrheals, Antimicrobials, Immunosuppressives, others

Disqualifiers: Pregnancy, Autoimmune disease, Diabetes, others

Compensation: Varies

Number of Visits: 13

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. ^{1 2 3 4 5}

Why 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. ^{3 4 5 6 7}

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

Access to CVD clinical site and available and willing to be followed for the planned duration of the study, including all follow-up visits

Completes a questionnaire prior to first treatment with verbal demonstration of understanding of all questionnaire items answered incorrectly

Agrees not to enroll in another study of an investigational research agent during the study, with exceptions

Exclusion Criteria

Other criteria affecting study participation

I have a bleeding disorder.

I have not received any blood products in the last 4 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Participants receive 1mL of bacteriophage preparation or placebo orally three times a day for 7 days to assess safety

1 week

Daily visits for 7 days

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

6 days

Daily visits for 6 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and immune response

Up to 90 days

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?

Group I: Bacteriophage Experimental Treatment 1 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: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Intralytix, Inc.

Lead Sponsor

Trials

3

Recruited

160+

University of Maryland, Baltimore

Collaborator

Trials

729

Recruited

540,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11429168/

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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05182749

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 ...

3. nature.com nature.com/articles/s44298-025-00155-4

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.

4. bmcmicrobiol.biomedcentral.com bmcmicrobiol.biomedcentral.com/articles/10.1186/s12866-025-04328-2

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 ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05182749/safety-and-efficacy-of-the-bacteriophage-preparation-shigactivetm-in-a-human-experimental-model-of-shigellosis?phase=5&id=69&slug=gastroenteritis

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 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39335031/

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 ...

7. mdpi.com mdpi.com/2079-6382/13/9/858

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 ...