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

NCT07569380 | Not Yet Recruiting

• 1 other identifier: LTO-CDI
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Clostridioides Difficile Infection

Keywords

Clostridioides difficile infection; Fecal microbiota transplantation; Gut microbiota; Microbiome engraftment; Intestinal barrier; Antibiotic treatment; Observational study

Outcome Measures

Primary Outcomes (1)

• Intestinal microbiota diversity

  Intestinal microbiota diversity assessed by metagenomic sequencing of stool samples.

  At follow-up visit 1-10 years after baseline CDI

Secondary Outcomes (6)

• Donor gut microbiota long-term engraftment

  At follow-up visit 1-10 years after baseline CDI

• Stool short-chain fatty acid concentrations

  At follow-up visit 1-10 years after baseline CDI

• Circulating markers of intestinal barrier function

  At follow-up visit 1-10 years after baseline CDI

• Health-related quality of life

  At follow-up visit 1-10 years after baseline CDI

• Number of participants with new Clostridioides difficile infection episodes after subsequent antibiotic exposure

  Within 1-10 years after baseline CDI

Study Arms (2)

Antibiotic treatment

Participants having received antibiotic-only treatment for previous Clostridioides difficile infection.

Fecal microbiota transplantation (FMT)

Participants having received FMT for previous Clostridioides difficile infection.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients that within the study period (2016-2024) have received treatment (antibiotic-only or FMT) at Umeå University Hospital.

You may qualify if:

• Adults aged 18 years or older
• Symptomatic, microbiologically verified index CDI from February 1 2016 to December 31 2024
• Having received CDI treatment at Umeå University Hospital (antibiotic-only or FMT)

You may not qualify if:

• Age below 18 years at follow-up
• Index CDI diagnosis not meeting ESCMID case definition
• Testing positive for another gastrointestinal pathogen (virus/bacteria) that is more plausible to explain the clinical picture at index CDI episode
• Declines participation

Sponsors & Collaborators

• Region Västerbotten: collaborator
• Umeå University: lead

Study Sites (1)

Umeå University Hospital

Umeå, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Fecal samples, nasopharyngeal swabs, urine samples, peripheral blood mononuclear cells, blood plasma and serum

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Johan Rasmuson, MD, PhD

  Umeå University, Department of Clinical Microbiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johan Rasmuson, MD, PhD

CONTACT

0046-907850000; johan.rasmuson@umu.se

Study Design

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

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 6, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): May 1, 2031
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)