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C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.

NCT07250724 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2026-01-12

No results posted yet for this study

Summary

Hospitals and clinics interested in participating in this multi-site study, please contact the people mentioned under "Contacts and Locations".

The goal of this study is to map the risk of having a C. Difficile infection recurrence (rCDI) after being treated with standard-of-care antibiotics for a C. Difficile infection.

The main questions it aims to answer are:

* What is the recurrence rate of CDI in the 8 weeks following antibiotic treatment for a first recurrence of CDI?
* Does toxin levels of Toxin A and/or B from C. Diff. at baseline predict CDI recurrence risk?

Participants will:

* Undergo standard of care Antibiotic treatment for first recurrence of CDI
* Visit their clinic at 4 different visits over a time period of approximately 9 weeks. (Visits can also be performed remote/via phone call.)

Conditions

  • Clostridioides Difficile Infection Recurrence

Interventions

OTHER

Participants that are undergoing standard of care antibiotic treatment for their second C. Diff infection will be followed for 8 weeks after completing antibiotic treatment.

Participants that are undergoing standard of care antibiotic treatment for their second C. Diff infection will be followed for 8 weeks after completing antibiotic treatment.

Sponsors & Collaborators

  • Bactolife A/S

    lead INDUSTRY

Principal Investigators

  • Brynjulf Mortensen, pHD · Bactolife A/S

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2026-10-15
Completion
2026-10-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07250724 on ClinicalTrials.gov