Trials Sponsors Conditions Drugs Pricing

Conditions

Clostridioides Difficile Infection Recurrence

Keywords

C. DiffClostridioides DifficileClostridioides Difficile InfectionClostridioides Difficile Infection RecurrenceClostridioides Difficile RecurrenceC. Diff recurrence

Outcome Measures

Primary Outcomes (1)

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

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.Other

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.

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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.

You may not qualify if:

Sponsors & Collaborators

Bactolife A/S
Industrylead

Study Sites (4)

Emory University Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

Jennifer C Truell, MA, MPHCONTACT404-778-0014 jennifer.carter.truell@emory.edu

Colleen S Kraft, MDCONTACT404-712-8889 colleen.kraft@emory.edu

Colleen S Kraft, MD, MScPRINCIPAL INVESTIGATOR

Nirja Mehta, MDSUB INVESTIGATOR

Corewell Health William Beaumont University Hospital

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples. DNA sequencing plenned, but only to look at bacterial DNA, not human DNA.

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

Brynjulf Mortensen, pHD
Bactolife A/S
STUDY DIRECTOR

Central Study Contacts

Kevin O' Regan Senior Operations Manager, Atlantia Clinical Trials

CONTACT

+1 312 818 8905 koregan@atlantiatrials.com

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 26, 2025

First Posted

November 26, 2025

Study Start

March 1, 2026

Actual (reported)

Primary Completion

October 15, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

Study Sites (4)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

Study Sites (4)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Source record

Locations