RecruitingNot Applicable

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

United States60 participantsStarted 2026-03-01

Plain-language 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.)

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Participants will be included in the study if they meet all of the following criteria At the time of screening: * Able to provide signed and dated informed consent * Males and females from the age of 18 and above * Planned or already ongoing SoC antibiotic treatment for diagnosed Clostridiodides difficile infection (CDI). All types of diagnosis/testing algorithms, and antibiotic taper regimes acceptable. * Documented history of, minimum one previous CDI episode occurring within the last 12 months. At the Time of Baseline Visit: \- Have completed the antibiotic treatment regime for the current CDI, a maximum of 5 days prior to the baseline visit Exclusion criteria 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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The proportion of subjects experiencing CDI recurrence in the time period between baseline and end of study follow-up.

Timeframe: Within the 8 week time period between baseline and end of follow-up

Trial details

NCT IDNCT07250724

SponsorBactolife A/S

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-10-15

Contact for this trial

Kevin O' Regan Senior Operations Manager, Atlantia Clinical Trials

+1 312 818 8905 koregan@atlantiatrials.com

View on ClinicalTrials.gov More Clostridioides Difficile Infection Recurrence trials