RecruitingNCT07250724

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

A Prospective, Observational Study to Evaluate C. Difficile Toxin Levels in Stool in Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.


Sponsor

Bactolife A/S

Enrollment

60 participants

Start Date

Feb 1, 2026

Study Type

OBSERVATIONAL

Conditions

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.)


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This multi-site observational study follows adults aged 18–75 who have recently completed antibiotic treatment for their first recurrence of Clostridioides difficile infection (CDI) — a gut infection causing severe diarrhea — to track whether the infection returns within 8 weeks. Researchers will also test stool samples for levels of C. difficile toxins at baseline, 2 weeks, and 8 weeks to explore whether toxin levels after treatment can predict who is at highest risk of a repeat infection. To be eligible, participants must have finished standard antibiotic therapy for their first rCDI no more than 5 days before enrollment and be symptom-free at the time of joining; those with active symptoms, planned additional CDI treatments, or significant chronic health conditions are excluded. Participation involves 4 clinic or remote visits over approximately 9 weeks and providing stool samples. This summary was prepared as patient-facing educational content using AI assistance.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERParticipants 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.


Locations(1)

Emory University Hospital

Atlanta, Georgia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07250724


Related Trials