Recruiting

Antibiotics

Sponsor:

Bactolife A/S

Code:

NCT07250724

Conditions

Clostridioides Difficile Infection Recurrence

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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.

Study Details

Brief 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.)

Conditions

Clostridioides Difficile Infection Recurrence

Study ID

NCT07250724

Start date

Mar 1, 2026

Status verified date

Jun, 2026

Completion date

Oct 15, 2026

Anticipated

Primary completion date

Oct 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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.

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Kevin O' Regan Senior Operations Manager, Atlantia Clinical Trials

+1 312 818 8905koregan@atlantiatrials.com

Locations

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Principal Investigator:

Colleen S Kraft, MD, MSc

Corewell Health William Beaumont University Hospital

Recruiting

Royal Oak, Michigan, United States, 48073

Contacts

Principal Investigator:

Matthew Sims, Dr.

Mayo Clinic, Minnesota

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Principal Investigator:

Darrell s Pardi, Dr.

University of Wisconsin-Madison

Recruiting

Madison, Wisconsin, United States, 53705-2281

Contacts

Principal Investigator:

Nasia Safdar, MD, PhD, Prof.

More Information

Sponsor

Bactolife A/S

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • C. Diff
  • Clostridioides Difficile
  • Clostridioides Difficile Infection
  • Clostridioides Difficile Infection Recurrence
  • Clostridioides Difficile Recurrence
  • C. Diff recurrence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bactolife A/S on 2026-06-15.