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

Recruiting now

Conditions studied: Clostridioides Difficile Infection Recurrence

In brief

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.)

Key facts

Study ID: NCT07250724
Run by: Bactolife A/S
People needed: 60
Starts: 2026-03-01
Expected to finish: 2026-10-15
Last updated by the study team: 2026-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Participants will be excluded from the study if they meet any of the following criteria:
At the time of screening:
Planned CDI recurrence treatment for the planned 8-week duration of study participation (I.e., Fecal microbiome transplant, Rebyota, Vowst, Live Biotherapeutic Products (LBPs), probiotics etc)
Pregnant or lactating women or women who intend/wish to become pregnant in the time period in between screening and visit 4
Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results. I.e.: Ostomized participants, Parenteral nutrition users, Patients with active Pancreatitis, Active, non-controlled intestinal diseases such as IBS, IBD, Crohn's Disease, ulcerative colitis, celiac disease, or other chronic diarrheal illness
Currently or recently taking a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results.
Individuals who, in the opinion of the investigator, are considered to be poor study attendees or unlikely for any reason to be able to comply with the study.
Participants may not be participating in other clinical studies, or planning to do so during participating in the present study. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results.
At the time of baseline visit:
Lack of CDI symptom resolution following the SoC antibiotic regime. I.e. still active diarrhoea (3 or more stools per 24-hour period) and within Bristol stool scale range of 5-7 at baseline.
Those who are on, or during study participation plan to go on, antibiotic treatment for any reason.

Where it is running

Emory University Hospital — Atlanta, Georgia, United States (enrolling)
Corewell Health William Beaumont University Hospital — Royal Oak, Michigan, United States (enrolling)
Mayo Clinic, Minnesota — Rochester, Minnesota, United States (enrolling)
University of Wisconsin-Madison — Madison, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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