이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2026년 4월 28일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

상세 설명

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.

연구 유형

관찰

등록 (추정된)

250

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 스웨덴
      • Umeå, 스웨덴
        • Umeå University Hospital
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Intestinal microbiota diversity
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Donor gut microbiota long-term engraftment
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Umeå University

협력자

Region Västerbotten

수사관

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 5월 1일

기본 완료 (추정된)

2026년 8월 1일

연구 완료 (추정된)

2031년 5월 1일

연구 등록 날짜

최초 제출

2026년 4월 21일

QC 기준을 충족하는 최초 제출

2026년 4월 28일

처음 게시됨 (실제)

2026년 5월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 4월 28일

마지막으로 확인됨

2026년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • LTO-CDI

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다