An observational study in Clostridioides Difficile Infection Recurrence, sponsored by Bactolife A/S. Active, not recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Bactolife A/S · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 121 studies in Clostridium Infections with a site in United States — 16 open to participants now, 19 under way, 3 of them phase 3. Clostridium Infections · United States.
Among the 121 studies in Clostridium Infections with a site in United States, this one is the 11th largest by planned enrollment of the 19 observational ones that give a count, is one of 8 that started in 2026, is one of 19 observational ones, reaches primary completion later than 5 of the 18 other live ones, and was the 115th registered.
251 studies on the registry are indexed under Clostridium Infections; 51 are open to participants now.
Browse Clostridium Infections studies →16 of the 121 studies in Clostridium Infections with a site in United States are open now. Recruiting first, the newest first:
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 18–75 · Healthy volunteers
Acurx Pharmaceuticals Inc. · Sites in United States
Ages 18–90
Medical College of Wisconsin · Sites in United States
Ages 18+
University of Michigan · Sites in United States
Ages 18+
AstraZeneca · Sites in United States, Australia, Canada and 11 more countries
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 36 Clostridium Infections studies recruiting now, 22 (61%) set no upper age limit and 8 (22%) stop at 75 or younger; 9 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
121 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 21 · Phase 2 40 · Phase 3 21 · Phase 4 14
First in 1998; this study’s year is marked. 8 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is below the median of 226 across 52 observational studies indexed under Clostridium Infections.
Median enrollment 57 across the 102 interventional studies, 132 across the 19 observational. Of the 91 that completed or were terminated, 52 (57%) have results posted.
This tab as a report to print or save as PDF → With an account.
48 of 121 have an industry lead sponsor. The 10 most frequent:
Bactolife A/S is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Bactolife A/S has 1 study filed under Clostridium Infections — fewer than ten, so there is no comparison to draw.
7 of the studies in Clostridium Infections with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07221370Phase 3Riverside University Health System Medical CenterEnteral Vancomycin as Primary Prophylaxis Against Clostridioides Difficile Infection in Critically Ill Patients | 2026-12-31 |
| NCT06237452Phase 3Vedanta Biosciences, Inc.VE303 for Prevention of Recurrent Clostridioides Difficile Infection | 2027-06 |
| NCT04305769University of VirginiaAlanyl-glutamine Supplementation for C. Difficile Treatment (ACT) | 2026-12-31 |
| NCT07250724Bactolife A/SC. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI. | 2027-01-15 |
| NCT07285213AstraZenecaPrevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody | 2027-04-20 |
Add all 7 to your calendar (.ics) → With an account.
Among the 121 studies in Clostridium Infections with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
Participants will:
Hospitals and clinics interested in participating in this multi-site study, please contact the people mentioned under "Contacts and Locations".
This prospective observational study will enrol 60 otherwise healthy adults with a documented history of first recurrent Clostridioides difficile infection (rCDI). Eligible participants must have had a confirmed positive toxin B test for C. difficile, with the initial infection occurring within the past 12 months. At the time of enrolment (Day 0), participants must have completed a standard-of-care oral antibiotic therapy for their first rCDI no more than five days prior and be asymptomatic for CDI. Potential participants will sign an informed consent form at their initial visit to their doctor (visit 1) and provide a stool sample for c diff testing. Participants will only be considered 'enrolled' if their stool sample is positive for toxin B and they meet all other criteria at visit 2 (week 0).
The primary objective of the study is to measure the rate of CDI recurrence within an 8-week follow-up period. The secondary objective is to assess stool levels of Toxin A and B at baseline, week 2, and week 8. The second objective will enable exploration of the reliability of using high-sensitivity assays for toxin detection in stool. Further, potential correlations between post-treatment stool toxin levels and rCDI development will be explored.
This prospective observational study will enrol 60 otherwise healthy adults with a documented history of first recurrent Clostridioides difficile infection (rCDI). Eligible participants must have had a confirmed positive toxin B test for C. difficile, with the initial infection occurring within the past 12 months. At the time of enrolment (Day 0), participants must have completed a standard-of-care oral antibiotic therapy for their first rCDI no more than five days prior and be asymptomatic for CDI. Potential participants will sign an informed consent form at their initial visit to their doctor (visit 1) and provide a stool sample for c diff testing. Participants will only be considered 'enrolled' if their stool sample is positive for toxin B and they meet all criteria at visit 2.
Participants will be included in the study if they meet all of the following criteria
At the time of screening:
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:
At the time of baseline visit:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
The proportion of subjects experiencing CDI recurrence in the time period between baseline and end of study 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.
Time frame: Within the 8 week time period between baseline and end of follow-up
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Jan 2027, 10 months after the start.
Of 26 observational studies under Clostridium Infections, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 22. This study's planned 10 months is below that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 4, 2026: primary completion Oct 2026 → Jan 2027 and completion Oct 2026 → Jan 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.