Actively Recruiting
C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.
Led by Bactolife A/S · Updated on 2026-01-12
60
Participants Needed
1
Research Sites
36 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide signed and dated informed consent
- Males and females between 18 - 75 years old inclusive
- Documented history of first recurrent Clostridioides difficile infection confirmed by positive toxin test within the previous 12 months
- Completed standard-of-care oral antibiotic therapy for first rCDI no more than 5 days before enrollment
- No symptoms of C. difficile infection at baseline (Day 0)
You will not qualify if you...
- Current episode of CDI or unresolved symptoms from previous recurrence
- Positive toxin A and negative toxin B test for C. difficile
- Planned CDI recurrence treatments during the study, such as fecal microbiome transplant or probiotics
- Ongoing antibiotic treatment after initial rCDI therapy
- Pregnant, lactating, or intending pregnancy within 3 months
- Active diarrhea (3 or more stools per 24 hours) with Bristol stool scale 5-7 at baseline
- Significant acute or chronic health conditions that risk safety or affect study results
- Ostomized participants or parenteral nutrition users
- Patients with active pancreatitis
- Active uncontrolled intestinal diseases like IBS, IBD, Crohn's disease, ulcerative colitis, celiac disease, or other chronic diarrheal illness
- Taking medications that may interfere with study or pose safety risk
- Considered unlikely to comply with study requirements
- Participating in other clinical studies or recently participated in experimental studies without sufficient time elapsed
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
K
Kevin O' Regan Senior Operations Manager, Atlantia Clinical Trials
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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