Can an enzyme shield the gut during transplant recovery?

NCT ID NCT04692181

Disease control Sponsor: Theriva Biologics, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests an oral enzyme called SYN-004 in adults who have received a stem cell transplant and need intravenous antibiotics for fever. The enzyme is designed to break down antibiotics in the gut, protecting the natural bacteria there. Researchers will check safety, whether the enzyme enters the blood, and if it helps prevent infections and improve outcomes. The trial involves 36 participants and is in early phases (1b/2a).

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: SYN-004 (Ribaxamase), an oral enzyme that breaks down certain antibiotics in the gut
What this could lead to: If it works, SYN-004 could help protect the gut microbiome during antibiotic treatment, potentially reducing infections and improving recovery in stem cell transplant patients.
What could go wrong: This is an early-phase trial with only 36 participants, so results may not apply broadly. The drug might not effectively protect the microbiome or could interfere with antibiotic levels in the blood.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2021

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participant provides written informed consent. 2. Male or female patients ≥18 years undergoing myeloablative allo-HCT for a hematologic malignancy or myeloproliferative disorder. 3. Participant is able to ingest the SYN-004 dosage form (size 0 hard capsule). Exclusion Criteria: 1. Allergy(ies) to MER, PIP, TAZO, or FEP. 2. History of allergy to SYN-004 or its components. 3. Admitted for HCT and started on MER, PIP/TAZO, or FEP prior to enrollment in the present study. 4. Currently enrolled in another interventional clinical study or received an investigational drug or device within 30 days or within a time period consistent with a washout period of 5 half-lives before signing the Informed Consent Form, whichever is longer. 5. Recipients of umbilical cord blood transplantation. 6. Underlying condition requiring HCT is not in remission (per International Working Group definitions), except for myelodysplastic syndrome and lymphoma, as long as these conditions are chemotherapy responsive. 7. Creatinine clearance \<60 mL/min/1.73 m² by Cockroft-Gault calculation. 8. Cardiac ejection fraction \<50%. 9. Cirrhosis, bilirubin \>1.5x upper limit of normal, or AST/ALT \>2.5x upper limit of normal. 10. History of veno-occlusive disease (VOD) or hepatic sinusoidal obstructive syndrome (SOS). 11. DLCO and/or FEV1 ≤80% of normal. 12. Chronic HIV or HBV infection. 13. Invasive fungal infection not responding to treatment at time of HCT. 14. Known active bacterial or viral infection at time of HCT. 15. CDI in the preceding 6 months. 16. Unable to comply with study protocol as determined by primary investigator. 17. Active gastrointestinal (GI) bleeding at time of HCT. 18. Prior colectomy or short gut syndrome. 19. Pregnant or breast feeding.

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Conditions

The condition(s) this trial relates to.

acute graft versus host disease hematopoietic and lymphoid cell neoplasm myeloproliferative neoplasm Clostridium difficile colitis prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute graft-versus-host reaction following bone marrow transplant Prevention of cdi in adult patients being treated with iv beta-lactam antibiotics

Can an enzyme shield the gut during transplant recovery?

What the study statuses mean