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

28 aprile 2026 aggiornato da: Umeå University

Long-Term Outcomes After Clostridioides Difficile Infection (CDI): Comparative Follow-Up of FMT Versus Antibiotic-Only Treatments (LTO-CDI Cohort)

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

Study design and setting This is a single-center, long-term observational cohort study conducted at the Department of Infectious Diseases, Umeå University Hospital, Sweden. The study enrolls adult patients treated for CDI between February 1, 2016 and December 31, 2024, providing up to 10 years of follow-up from the index CDI episode. Participants are stratified into two groups: FMT-treated and antibiotic-only treated.

CDI case definition Compatible clinical presentation (≥3 loose stools in 24 hours) plus a positive nucleic acid amplification test (LAMP) for C. difficile, consistent with ESCMID diagnostic criteria.

Recruitment Potentially eligible living subjects are identified from departmental diagnosis records and contacted by mail with written study information and an opt-out form. Those who do not return the opt-out form are contacted by telephone and invited to a single study visit for informed consent and enrollment. Deceased individuals are included in safety analyses only, without contact with next of kin.

Biological sampling Blood: EDTA plasma, serum, PBMC isolation Fecal sample Urine sample Nasopharyngeal swab

Archived donor fecal samples and pre- and post-FMT patient samples from the Umeå FMT biobank will be retrieved for longitudinal comparisons.

Observational measures Gut and nasopharyngeal microbiota will be characterized by shotgun metagenomics (strain-level resolution) and 16S rRNA sequencing. Resistome profiling and detection of multidrug-resistant organisms by culture will be performed on fecal samples. Global and targeted metabolomics (short-chain fatty acids, bile acids, redox metabolites) will be performed on feces, urine, and blood. Gut barrier markers in blood will include LPS, LPS-binding protein (LBP), and EndoCAb. Systemic immune profiling will include cytokine panels, soluble immune mediators, antibodies, and transcriptomic profiling of peripheral blood mononuclear cells. The host genome will not be sequenced. Clinical observational measures will include additional CDI after index CDI. Pharmacological treatments and comorbidity at index CDI and follow-up, as well as any antibiotic exposure during follow-up will be collected from the medical records.

Tipo di studio

Osservativo

Iscrizione (Stimato)

250

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Svezia
      • Umeå, Svezia
        • Umeå University Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Intestinal microbiota diversity
Lasso di tempo: At follow-up visit 1-10 years after baseline CDI
Intestinal microbiota diversity assessed by metagenomic sequencing of stool samples.
At follow-up visit 1-10 years after baseline CDI

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Donor gut microbiota long-term engraftment
Lasso di tempo: At follow-up visit 1-10 years after baseline CDI
Assessment of donor gut microbiota engraftment in participants stool samples 1-10 years post FMT, performed by metagenomic sequencing.
At follow-up visit 1-10 years after baseline CDI
Stool short-chain fatty acid concentrations
Lasso di tempo: At follow-up visit 1-10 years after baseline CDI
Stool short-chain fatty acid concentrations assessed using metabolomic methods.
At follow-up visit 1-10 years after baseline CDI
Circulating markers of intestinal barrier function
Lasso di tempo: At follow-up visit 1-10 years after baseline CDI
Circulating biomarkers related to intestinal barrier function measured in peripheral blood.
At follow-up visit 1-10 years after baseline CDI
Health-related quality of life
Lasso di tempo: At follow-up visit 1-10 years after baseline CDI
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.
At follow-up visit 1-10 years after baseline CDI
Number of participants with new Clostridioides difficile infection episodes after subsequent antibiotic exposure
Lasso di tempo: Within 1-10 years after baseline CDI
Occurrence of new Clostridioides difficile infection episodes following exposure to non-CDI antibiotic treatment during follow-up.
Within 1-10 years after baseline CDI
Incidence of new comorbidities after FMT versus antibiotic-only treatment
Lasso di tempo: From baseline CDI to 1-10 year follow-up or prior death
Incidence of new diagnoses (autoimmune, autoinflammatory, neoplastic, and metabolic conditions) in FMT-treated participants compared with antibiotic-only treated participants, ascertained from medical records using ICD-10 diagnostic codes.
From baseline CDI to 1-10 year follow-up or prior death

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Umeå University

Collaboratori

Region Västerbotten

Investigatori

  • Investigatore principale: Johan Rasmuson, MD, PhD, Umeå University, Department of Clinical Microbiology

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 maggio 2026

Completamento primario (Stimato)

1 agosto 2026

Completamento dello studio (Stimato)

1 maggio 2031

Date di iscrizione allo studio

Primo inviato

21 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 aprile 2026

Primo Inserito (Effettivo)

6 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • LTO-CDI

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be shared due to the sensitive nature of the clinical and biological data collected in this observational study.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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