How antibiotics versus fecal transplants affect recovery from C. difficile infection
Official title: Studies of Treatment Effects, Host-Pathogen Responses, and Therapeutic Mechanisms in Clostridioides Difficile Infection
Run by Umeå University · NCT07374094 · Data updated 2026-11-12
This project will see how antibiotics and fecal microbiota transplant (FMT) affect adults with C. difficile infection by tracking recovery and biological changes over time.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Umeå University Academic / other |
| Locations | 1 site (Umeå) |
| Status | Recruiting |
| Started | January 26, 2026 |
| Main results expected | December 2040 |
| Study ends | December 2045 |
| Registry record updated | January 28, 2026 |
| Trial ID | NCT07374094 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with symptomatic, laboratory‑confirmed C. difficile infection receiving inpatient or outpatient care at Umeå University Hospital who can provide written informed consent and attend follow‑up are ideal candidates.
✕Probably not a fit
Patients under 18, those unable to provide written consent, or people treated outside Umeå University Hospital are not eligible and will not benefit directly from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project follows adults with microbiologically confirmed C. difficile infection who receive routine care with either standard antibiotics or fecal microbiota transplantation (FMT). Treatment decisions are made by the treating physician and the research team collects stool and other biological samples during the acute episode and at predefined follow‑up visits for up to five years. Samples will be analyzed for microbiota composition, microbial metabolites, intestinal barrier markers, and mucosal and systemic immune responses and these measures will be related to clinical outcomes and patient‑reported quality of life. The study aims to identify microbial and metabolic signatures linked to recovery or treatment failure and to characterize short‑ and long‑term effects of each therapy.
Why it matters
Potential benefit: If successful, results could help clinicians choose the most appropriate therapy and reduce recurrences by predicting who is most likely to recover with antibiotics versus FMT.
How similar studies have gone: Other studies have shown FMT is highly effective for recurrent C. difficile and smaller microbiome studies link microbial shifts to outcomes, but detailed mechanistic data and long‑term profiling are still limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 years or older * Symptomatic, microbiologically verified Clostridioides difficile infection * Receiving inpatient or outpatient care at Umeå University Hospital * Able and willing to provide written informed consent * Willing to participate in protocol-driven follow-up for up to 5 years Exclusion Criteria: * Age below 18 years * Inability to provide written informed consent
Where it's running
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Umeå University Hospital
Umeå, Sweden Recruiting
Study contacts
- Principal investigator: Johan Rasmuson, MD, PhD — Umeå University, Department of Clinical Microbiology and Umeå University Hospital, Department of Infectious Diseases
- Study coordinator: Johan Rasmuson, MD, PhD
- Email: johan.rasmuson@umu.se
- Phone: 0046-907850000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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We’re testing whether different meal plans and health counseling can influence the gut microbiome and reduce chances of CDI coming back in adults who are being treated for CDI.
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This trial tests whether taking short-course oral vancomycin while you need systemic antibiotics can prevent a recurrence of C. difficile in adults recently treated for CDI.
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UDCA added to standard therapy to prevent C. diff recurrence
This study tests whether taking ursodeoxycholic acid alongside standard antibiotics can reduce recurrence of C. difficile colitis in adults at risk.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.