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.
Przegląd badań
Status
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Johan Rasmuson, MD, PhD
- Numer telefonu: 0046-907850000
- E-mail: johan.rasmuson@umu.se
Lokalizacje studiów
-
-
-
Umeå, Szwecja
- Umeå University Hospital
-
Kontakt:
- Johan Rasmuson, MD, PhD
- Numer telefonu: 0046-907850000
- E-mail: johan.rasmuson@umu.se
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
|---|
|
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Intestinal microbiota diversity
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Donor gut microbiota long-term engraftment
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Johan Rasmuson, MD, PhD, Umeå University, Department of Clinical Microbiology
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- LTO-CDI
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .