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C. Difficile Toxin Levels After Standard Antibiotic Treatment

This observational study is looking at people who have had a second C. Difficile infection (CDI) and are being treated with standard antibiotics. The main goal is to understand how often C. Difficile infections come back within 8 weeks after finishing antibiotic treatment. Researchers also want to see if the levels of C. Difficile toxins (Toxin A and/or B) in your stool at the beginning of the study can predict if your infection will return. You can join if you are 18 or older, have a diagnosed C. Difficile infection, and are receiving standard antibiotic treatment. The study plans to enroll 60 participants.

Study design
This is an observational study with 60 planned participants. It is not specified if it is randomized or blinded.
What's involved
You will undergo standard antibiotic treatment for your C. Difficile infection and have four clinic visits over about nine weeks. You will also provide a stool sample for testing.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 8 weeks after completing antibiotic treatment.

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NCT07250724

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

Recruiting
Not specifiedAges 18+Observational
Bactolife A/S
~60 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested: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.

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The proportion of subjects experiencing CDI recurrence in the time period between baseline and end of study follow-up.
Measured over Within the 8 week time period between baseline and end of follow-up

Conditions

Clostridioides Difficile Infection Recurrence

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Clostridium difficile Infection

Where it's being run

4 sites across 4 states
Georgia1
Michigan1
Minnesota1
Wisconsin1

Study leadership

  • Brynjulf Mortensen, pHD · STUDY_DIRECTOR · Bactolife A/S

Who to contact

Kevin O' Regan Senior Operations Manager, Atlantia Clinical Trials
[email protected]
+1 312 818 8905
Email the study team

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Eligibility criteria

Exclusion

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.
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.

What this trial measures

  • The proportion of subjects experiencing CDI recurrence in the time period between baseline and end of study follow-up.Within the 8 week time period between baseline and end of follow-up

    CDI recurrence will be defined as the development of a new episode of diarrhoea (3 or more loose stools in 24 or fewer hours) associated with a positive stool test for toxigenic C. difficile following clinical cure of the initial CDI episode.