Clinical Trial

Long-Term Outcomes After CDI: FMT Versus Antibiotic-Only Treatment

Study acronym: LTO-CDI
Not Yet Recruiting
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Record status
This record was last updated May 6, 2026 (before its estimated August 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this observational study is to learn about the long-term effects of fecal microbiota transplantation (FMT) compared with antibiotic-only treatment in adults who were treated for Clostridioides difficile infection (CDI) at Umeå University Hospital between 2016 and 2024. The main questions it aims to answer are: * Do patients treated with FMT maintain higher gut bacterial diversity up to 10 years after CDI compared with patients treated with antibiotics only? * Do donor gut bacteria introduced by FMT persist long-term in the recipient's gut? * Are there differences in gut metabolism, gut barrier function, and systemic inflammation between FMT-treated and antibiotic-only treated patients at long-term follow-up? * What are the long-term safety outcomes - including new diseases, hospitalizations, and mortality - in FMT-treated versus antibiotic-only treated patients? Researchers will compare patients who received FMT to patients who received antibiotics only to see if FMT leads to lasting differences in gut microbiota, metabolism, immune markers, and clinical outcomes. Participants will: * Attend a single study visit at Umeå University Hospital * Provide samples of blood, stool, urine, and a nasal swab * Complete two quality-of-life questionnaires Clinical data will be collected from medical records for all participants.
Trial Details
NCT Number NCT07569380
Lead Sponsor Umeå University
Collaborators: Region Västerbotten
Conditions Clostridioides Difficile Infection
Enrollment 250 participants
Start Date 2026-05-01
Primary Completion 2026-08-01 (estimated)
Study Completion 2031-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-06