Actively Recruiting
A Prospective Observational Study Evaluating C. Difficile Toxin Levels in Stool After Standard Antibiotic Treatment for Clostridioides difficile Infection Recurrence
Led by Bactolife A/S · Updated on 2026-05-28
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand the risk of recurrence of Clostridioides difficile infection (CDI) after initial antibiotic treatment for a first recurrence. It focuses on adults who have completed standard antibiotic therapy for their first recurrent CDI and are currently asymptomatic. The study will evaluate how often CDI returns within eight weeks and whether levels of C. difficile toxins A and B in stool can predict this risk. Participants will be followed after finishing their standard oral antibiotic treatment for CDI. The study includes four clinic visits over about nine weeks, which can also be done remotely by phone. Stool samples will be collected at baseline, week 2, and week 8 to measure toxin levels using sensitive tests. This observational study seeks to explore the connection between toxin presence after treatment and the chance of infection returning. During the study, participants will provide stool samples and undergo assessments at scheduled visits. Researchers will monitor for CDI recurrence during the eight-week follow-up and analyze toxin levels in stool samples. The main outcome measured is the proportion of participants experiencing CDI recurrence within this period. Participants’ health and safety will be observed throughout the study, which lasts approximately nine weeks.
CONDITIONS
Brief 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 and 75 years old inclusive
- Documented history of first recurrent Clostridioides difficile infection with positive toxin test within the past 12 months
- Completed standard oral antibiotic therapy for the first recurrent CDI within 5 days before enrollment
- No CDI-related symptoms at the time of enrollment
You will not qualify if you...
- Current episode of CDI or unresolved symptoms from previous recurrence
- Positive test for Toxin A only without Toxin B
- Planned CDI treatments during the study like fecal microbiome transplant or probiotics
- Receiving additional antibiotic treatments after initial rCDI therapy
- Pregnant, lactating, or planning pregnancy within 3 months
- Active diarrhea with 3 or more stools per day and Bristol stool scale 5-7 at baseline
- Significant acute or chronic health conditions that risk safety or confound results
- Use of parenteral nutrition or ostomy
- Active pancreatitis or uncontrolled intestinal diseases like IBS, IBD, Crohn's disease, ulcerative colitis, or celiac disease
- Taking medications that interfere with study objectives or pose safety risks
- Unlikely to comply with study requirements
- Currently participating in other clinical studies or insufficient time since last experimental study participation to ensure result integrity
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) to provide informed consent and stool sample for testing
Duration - 8 weeks
Participants who have completed standard antibiotic treatment for Clostridioides difficile infection are observed to assess stool toxin levels and monitor for infection recurrence.
3 visits at baseline, Week 2, and Week 8 for stool sample collection and assessments
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
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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