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

52 Participants Needed

Trial Summary

What is the purpose of this trial?

The study is a first-in-human Phase 1/2a randomized, double-blind, placebo-controlled trial to assess the clinical safety and efficacy of ShigActive in healthy adults with experimental Shigella challenge.

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.

What data supports the effectiveness of the treatment ShigActive™ for Shigellosis?

Research shows that ShigActive™, a phage cocktail, significantly reduces Shigella bacteria in mice without harmful side effects, suggesting it could be an effective treatment for Shigellosis in humans. ^{1 2 3 4 5}

Is bacteriophage therapy for Shigellosis safe for humans?

Research on bacteriophage therapy, including a product called ShigActive™, shows it is generally safe, with no harmful side effects or disruptions to gut health observed in animal studies. Phage therapy has a proven long-term safety profile and is being explored as a safe alternative to antibiotics for treating infections. ^{1 2 3 5 6}

How is the treatment ShigActive™ different from other treatments for shigellosis?

ShigActive™ is unique because it uses bacteriophage therapy, which involves viruses that specifically target and destroy bacteria, offering a promising alternative to antibiotics, especially for multidrug-resistant strains of Shigella. ^{1 2 4 5 7}

Research Team

Alexander Sulakvelidze, PhD

Principal Investigator

Intralytix, Inc.

Wilbur Chen Chen, MD, MS

Principal Investigator

University of Maryland, Baltimore, Center for Vaccine Development and Global Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy and potential of phage therapy against multidrug resistant Shigella spp. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A New Phage Cocktail Against Multidrug, ESBL-Producer Isolates of Shigella sonnei and Shigella flexneri with Highly Efficient Bacteriolytic Activity. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Bacteriophage administration significantly reduces Shigella colonization and shedding by Shigella-challenged mice without deleterious side effects and distortions in the gut microbiota. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Bacteriophages for managing Shigella in various clinical and non-clinical settings. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Genomic and Proteomic Characterizations of Sfin-1, a Novel Lytic Phage Infecting Multidrug-Resistant Shigella spp. and Escherichia coli C. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Design of a Bacteriophage Cocktail Active against Shigella Species and Testing of Its Therapeutic Potential in Galleria mellonella. [2022]

7. England pubmed.ncbi.nlm.nih.gov

An in-vitro study on a novel six-phage cocktail against multi-drug resistant-ESBL Shigella in aquatic environment. [2021]