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

28. april 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

250

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Sverige
      • Umeå, Sverige
        • Umeå University Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Intestinal microbiota diversity
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Donor gut microbiota long-term engraftment
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Umeå University

Samarbeidspartnere

Region Västerbotten

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. mai 2026

Primær fullføring (Antatt)

1. august 2026

Studiet fullført (Antatt)

1. mai 2031

Datoer for studieregistrering

Først innsendt

21. april 2026

Først innsendt som oppfylte QC-kriteriene

28. april 2026

Først lagt ut (Faktiske)

6. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • LTO-CDI

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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