Long-Term Outcomes After CDI: FMT Versus Antibiotic-Only Treatment
ConditionClostridioides Difficile Infection
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUmeå University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial population
Patients that within the study period (2016-2024) have received treatment (antibiotic-only or FMT) at Umeå University Hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
250 Participants
are grouped into 2 trial groupsGroup A: Antibiotic treatment
Group B: Fecal microbiota transplantation (FMT)
Trial outcomes
Primary outcomes
1
Intestinal microbiota diversity
Intestinal microbiota diversity assessed by metagenomic sequencing of stool samples.
Time frame
At follow-up visit 1-10 years after baseline CDISecondary outcomes
1
Donor gut microbiota long-term engraftment
Assessment of donor gut microbiota engraftment in participants stool samples 1-10 years post FMT, performed by metagenomic sequencing.
Time frame
At follow-up visit 1-10 years after baseline CDI2
Stool short-chain fatty acid concentrations
Stool short-chain fatty acid concentrations assessed using metabolomic methods.
Time frame
At follow-up visit 1-10 years after baseline CDI3
Circulating markers of intestinal barrier function
Circulating biomarkers related to intestinal barrier function measured in peripheral blood.
Time frame
At follow-up visit 1-10 years after baseline CDI4
Health-related quality of life
Patient-reported health-related quality of life assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The descriptive system comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five levels (no problems to extreme problems), producing a 5-digit health state profile. Higher index values indicate better health-related quality of life.
Time frame
At follow-up visit 1-10 years after baseline CDISponsors and contacts
Click on the lead sponsor to view all of their trials.
Umeå University
Lead sponsor
Region Västerbotten
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: