---
title: "Early oral fecal microbiota transplantation versus vancomycin or fidaxomicin for first or first-re"
id: "bmj-open-13-fecal-microbiota-transplantation-versus-vancomycin-or-fidaxomicin-in"
canonical_url: "https://medichelpline.com/clinical-feed/bmj-open-13-fecal-microbiota-transplantation-versus-vancomycin-or-fidaxomicin-in"
content_type: "clinical_feed_article"
specialty: "Infectious Disease"
source_name: "BMJ Open"
source_url: "http://bmjopen.bmj.com/cgi/content/short/16/8/e119480?rss=1"
published_at: "2026-08-28T09:38:04.000Z"
evidence_level: "Journal Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Early oral fecal microbiota transplantation versus vancomycin or fidaxomicin for first or first-re
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/bmj-open-13-fecal-microbiota-transplantation-versus-vancomycin-or-fidaxomicin-in
- **Specialty:** [Infectious Disease](https://medichelpline.com/clinical-feed/infectious-disease.md)
- **Primary Source:** BMJ Open
- **Source URL:** [Original Journal Publication](http://bmjopen.bmj.com/cgi/content/short/16/8/e119480?rss=1)
- **Published At:** 2026-08-28T09:38:04.000Z
- **Evidence Rating:** Journal Feed
## Executive GIST (TL;DR)
- Clostridioides difficile infection (CDI) causes significant healthcare-associated diarrhoea with recurrence rates of 15%–25% after a first episode and up to 65% after multiple recurrences. Recurrent CDI worsens morbidity, quality of life, antimicrobial exposure and healthcare use. - **Faecal microbiota transplantation (FMT)** is highly effective for multiple recurrent CDI, but evidence is limited for its use earlier: after the first episode in patients at high risk of recurrence or after the first recurrence. - This protocol describes a multicentre, randomised, open-label, pragmatic phase III superiority trial conducted at eight Swiss centres, enrolling 100 adults. - Eligible participants are adults with either a first CDI episode plus risk factors for recurrence or a first CDI recurrence; all receive standard-of-care antibiotics (10 days of **vancomycin** or **fidaxomicin**) before randomisation. - Randomisation is 1:1 to adjunctive **oral FMT** following antibiotics versus standard therapy alone. The intervention is administered 12 hours to 4 days after the last antibiotic dose as 15–20 oral capsules twice on two consecutive days for non-severe CDI; severe CDI receives an additional 2-day FMT course. - The primary outcome is proportion with CDI recurrence at 8 weeks after treatment completion, analysed per-protocol and intention-to-treat. - Secondary outcomes include early and late recurrence rates, sustained cure at 6 and 12 months, quality-adjusted life years, recurrence-free and overall survival at 12 months, plus safety and tolerability. - Exploratory analyses assess gut microbiota diversity, biomarker discovery and immunologic and microbial predictors of recurrence. - The trial adheres to ICH Good Clinical Practice, the Declaration of Helsinki and Swiss regulations; results will be published and presented. Trial registration: NCT05266807.
## Clinical Analysis & Structured Key Points
Introduction Clostridioides difficile infection (CDI) is a leading cause of healthcare-associated diarrhoea in adults, with recurrence rates of 15% - 25% after a first episode and up to 65% after multiple recurrences. Recurrent CDI leads to significant morbidity, diminished quality of life, prolonged antimicrobial exposure and increased healthcare utilisation. Faecal microbiota transplantation (FMT) demonstrates high efficacy for multiple recurrent CDI, but its benefit when used earlier - after the first episode in high-risk patients or first recurrence - remains insufficiently studied. Emerging evidence suggests early FMT may improve sustained clinical cure rates and reduce recurrence. This trial evaluates whether early introduction of oral FMT following standard therapy improves outcomes compared with standard therapy alone. Methods and analysis This is a multicentre, randomised, open-label, pragmatic phase III superiority clinical trial conducted across eight Swiss clinical centres. A total of 100 adults will be enrolled. Patients with either (1) a first CDI episode and risk factors for recurrence or (2) a first CDI recurrence and who first receive the real-world standard of care anti-CDI antibiotics (10 days of vancomycin or fidaxomicin) are randomised 1:1 to oral FMT following standard antibiotic therapy or standard therapy alone. The intervention group receives within 12 hours to 4 days of the last antibiotics administration, 15 to 20 oral FMT capsules twice on two consecutive days if the CDI is non-severe; those with severe CDI receive an additional 2-day FMT course. The control group does not receive any additional treatment after completing the 10 days of standard therapy. The primary endpoint is the proportion of patients having experienced a CDI recurrence at 8 weeks post completion of treatment (assessed per-protocol and intention-to-treat). Secondary outcomes include early and late recurrence rates, sustained cure at 6 and 12 months, quality-adjusted life years, recurrence-free and overall survival at 12 months. Exploratory analyses include microbiota diversity, biomarker identification and assessment of immunologic and microbial predictors of recurrence. Safety/tolerability is also assessed. Ethics and dissemination The study will be conducted in accordance with International Council for Harmonisation Good Clinical Practice, the Declaration of Helsinki and Swiss regulatory standards. Results will be disseminated through peer-reviewed publications and conference presentations. Trial registration number NCT05266807 .
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