Study on the Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in the Treatment of Functional Gastrointestinal Disorders
This study is designed to explore the efficacy and safety of fecal microbiota transplantation (FMT) with different delivery routes for patients with functional gastrointestinal disorders (FGIDs). The response to FMT varies greatly, which is related to donor selection, administration route, individual patient characteristics and microbiota compatibility. This single-center, prospective randomized controlled trial plans to enroll 200 FGID patients refractory to conventional medications from OCT 2026 to OCT 2029. Eligible participants will be randomized into a conventional medication group or an FMT group; the FMT group will be further randomized into three subgroups according to transplantation routes: oral capsule, nasojejunal tube and colonoscopic administration. Clinical data, laboratory, imaging and endoscopic results will be collected. Gut microbiota and metabolites will be analyzed before and after treatment. Clinical efficacy and safety will be evaluated at week 12.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Yanyun Fan, PhD
- 전화번호: +86 592 2291429
- 이메일: fanyanyun@xmu.edu.cn
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
-
1: Aged 1865 years, regardless of gender;
2: Meeting the Rome IV diagnostic criteria (independently confirmed by two physicians with associate-senior title or above), including subtypes of irritable bowel syndrome: IBS-D (diarrhea-predominant), IBS-C (constipation-predominant), and IBS-M (mixed-type).
3: Patients with functional constipation (excluding defecatory disorder-related constipation), functional diarrhea, or functional bloating, who have poor response to or intolerance of at least one conventional pharmacotherapy (e.g., antispasmodics, antidiarrheals, osmotic laxatives), with a disease duration of ≥6 months.
4: Voluntarily participating in this study, signing a written informed consent form, and committing to comply with the study protocol.
Exclusion Criteria:
-
1: History of prior colectomy or planned surgery within 6 months
2: contraindications to colonoscopy (severe luminal stenosis, toxic megacolon, risk of perforation, etc.)
3: comorbid diagnoses: uncontrolled infectious enteritis, positive Clostridioides difficile test, intestinal ischemia, radiation colitis, active diverticular disease
4: ast or present history of active tuberculosis, active hepatitis B / hepatitis C / HIV infection opportunistic infections
5: severe systemic diseases: decompensated liver cirrhosis, NYHA Class Ⅲ-Ⅳ heart failure, renal insufficiency (eGFR<30 ml/min)
6: concomitant malignant tumor or lymphoma
7: severe immunodeficiency or long-term use of immunosuppressants or systemic glucocorticoids.
8: Pregnancy, lactation, or planned pregnancy within 6 months
9: allergy to FMT or study-related medications (laxatives, PPIs, etc.);
10: poor compliance, psychiatric disorders,or any other conditions deemed by investigators to render the subject unsuitable for participation in the study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Oral capsule FMT group
Fecal microbiota transplantation via oral capsule combined with conventional symptomatic treatment for functional gastrointestinal disorders. |
FMT prepared from screened donor stool, administered by oral capsules, combined with conventional symptomatic treatment. |
|
실험적: Nasojejunal tube FMT group
Fecal microbiota transplantation delivered through nasojejunal tube combined with conventional symptomatic treatment for functional gastrointestinal disorders. |
FMT prepared from screened donor stool, infused via nasojejunal tube, combined with conventional symptomatic treatment. |
|
실험적: Colonoscopic FMT group
Fecal microbiota transplantation administered by colonoscopic catheter combined with conventional symptomatic treatment for functional gastrointestinal disorders. |
FMT prepared from screened donor stool, delivered through colonoscopic catheter, combined with conventional symptomatic treatment. |
|
활성 비교기: Conventional medication group
Routine symptomatic drug treatment for functional gastrointestinal disorders without fecal microbiota transplantation. |
Routine symptomatic drugs for functional gastrointestinal disorders, without fecal microbiota transplantation. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Clinical response rate at week 12
기간: 12 weeks after enrollment
|
The proportion of participants achieving clinical response (≥50% reduction in symptom score). Compare treatment responses across FGID subtypes (IBS-C, IBS-D, mixed IBS, functional constipation, functional diarrhea, functional bloating), and compare efficacy among three FMT administration routes. |
12 weeks after enrollment
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Adverse events of FMT
기간: From FMT initiation to week 12
|
The type, frequency and severity of adverse events during transplantation, within 4 weeks (short-term) and within 12 weeks (long-term) after transplantation; compare route-related safety risks. |
From FMT initiation to week 12
|
|
Change in quality of life assessed by the Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire
기간: Baseline, week 12
|
The Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire, ranging from 0 to 100. Higher scores indicate worse quality of life. Assessments will be performed at baseline and week 12. |
Baseline, week 12
|
|
Change in gut microbial alpha-diversity
기간: Baseline, week 12
|
Gut microbial alpha-diversity (e.g., Shannon index, Chao1 index). Fecal samples will be collected for 16S rRNA sequencing. |
Baseline, week 12
|
|
Change in quality of life assessed by the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire
기간: Baseline, week 12
|
The Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire, ranging from 0 to 112. Higher scores indicate worse quality of life. Assessments will be performed at baseline and week 12. |
Baseline, week 12
|
|
Change in gut microbial beta-diversity
기간: Baseline, week 12
|
Gut microbial beta-diversity, reflecting overall dissimilarity of microbial community composition. Fecal samples will be collected for 16S rRNA sequencing. |
Baseline, week 12
|
|
Changes in relative abundance of beneficial taxa and microbiota engraftment
기간: Baseline, week 12
|
Relative abundance of beneficial bacterial taxa and the degree of microbiota engraftment toward donor microbial profiles. Fecal samples will be collected for 16S rRNA sequencing. |
Baseline, week 12
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- MR-35-26-081205
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .