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

28. April 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

250

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Schweden
      • Umeå, Schweden
        • Umeå University Hospital
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Intestinal microbiota diversity
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Donor gut microbiota long-term engraftment
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Umeå University

Mitarbeiter

Region Västerbotten

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Mai 2026

Primärer Abschluss (Geschätzt)

1. August 2026

Studienabschluss (Geschätzt)

1. Mai 2031

Studienanmeldedaten

Zuerst eingereicht

21. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. April 2026

Zuerst gepostet (Tatsächlich)

6. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. April 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • LTO-CDI

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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