Long-Term Outcomes After CDI: FMT Versus Antibiotic-Only Treatment (LTO-CDI)
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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 de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Johan Rasmuson, MD, PhD
- Número de teléfono: 0046-907850000
- Correo electrónico: johan.rasmuson@umu.se
Ubicaciones de estudio
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Umeå, Suecia
- Umeå University Hospital
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Contacto:
- Johan Rasmuson, MD, PhD
- Número de teléfono: 0046-907850000
- Correo electrónico: johan.rasmuson@umu.se
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Antibiotic treatment
Participants having received antibiotic-only treatment for previous Clostridioides difficile infection.
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Fecal microbiota transplantation (FMT)
Participants having received FMT for previous Clostridioides difficile infection.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Intestinal microbiota diversity
Periodo de tiempo: At follow-up visit 1-10 years after baseline CDI
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Intestinal microbiota diversity assessed by metagenomic sequencing of stool samples.
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At follow-up visit 1-10 years after baseline CDI
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Donor gut microbiota long-term engraftment
Periodo de tiempo: At follow-up visit 1-10 years after baseline CDI
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Assessment of donor gut microbiota engraftment in participants stool samples 1-10 years post FMT, performed by metagenomic sequencing.
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At follow-up visit 1-10 years after baseline CDI
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Stool short-chain fatty acid concentrations
Periodo de tiempo: At follow-up visit 1-10 years after baseline CDI
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Stool short-chain fatty acid concentrations assessed using metabolomic methods.
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At follow-up visit 1-10 years after baseline CDI
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Circulating markers of intestinal barrier function
Periodo de tiempo: At follow-up visit 1-10 years after baseline CDI
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Circulating biomarkers related to intestinal barrier function measured in peripheral blood.
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At follow-up visit 1-10 years after baseline CDI
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Health-related quality of life
Periodo de tiempo: At follow-up visit 1-10 years after baseline CDI
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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.
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At follow-up visit 1-10 years after baseline CDI
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Number of participants with new Clostridioides difficile infection episodes after subsequent antibiotic exposure
Periodo de tiempo: Within 1-10 years after baseline CDI
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Occurrence of new Clostridioides difficile infection episodes following exposure to non-CDI antibiotic treatment during follow-up.
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Within 1-10 years after baseline CDI
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Incidence of new comorbidities after FMT versus antibiotic-only treatment
Periodo de tiempo: From baseline CDI to 1-10 year follow-up or prior death
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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.
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From baseline CDI to 1-10 year follow-up or prior death
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Johan Rasmuson, MD, PhD, Umeå University, Department of Clinical Microbiology
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- LTO-CDI
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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