How antibiotics versus fecal transplants affect recovery from C. difficile infection
Studies of Treatment Effects, Host-Pathogen Responses, and Therapeutic Mechanisms in Clostridioides Difficile Infection
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Umeå University Academic / other |
| Locations | 1 site (Umeå) |
| Trial ID | NCT07374094 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Umeå
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.