Autologous Fecal Microbiota Transplantation for Anal Function Recovery After Ileostomy Reversal in Rectal Cancer
Autologous Fecal Microbiota Transplantation for Anal Function Recovery After Ileostomy Reversal in Patients With Rectal Cancer: A Prospective, Single-center, Single-arm, Open-label Clinical Study
연구 개요
상태
상세 설명
Patients with rectal cancer who undergo radical resection with protective loop ileostomy may experience diversion-related changes in the distal bowel, gut microbiota dysbiosis, diversion colitis, and impaired bowel function after ileostomy reversal. Autologous fecal microbiota transplantation may help restore the intestinal microbial environment in the defunctioned bowel and improve postoperative bowel function.
In this study, eligible patients will undergo standard radical rectal cancer surgery with protective loop ileostomy. At approximately 8 weeks after surgery, patients without severe postoperative complications such as anastomotic leakage will undergo anal swab sampling for 16S rRNA gene sequencing. Autologous fecal microbiota transplantation will be performed once weekly at postoperative weeks 8, 9, 10, and 11. At approximately 12 weeks after surgery, colonoscopy will be performed to evaluate the distal bowel mucosa, and intestinal secretion samples will be collected for 16S rRNA gene sequencing. Ileostomy reversal will then be performed according to routine clinical practice. Bowel function will be followed for 3 months after ileostomy reversal, with the primary endpoint being the LARS score at 3 months after reversal.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Beijing Municipality
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Beijing, Beijing Municipality, 중국, 100044
- Peking University People's Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age 18 to 75 years.
- Histologically or clinically confirmed rectal cancer with the lower tumor margin less than 12 cm from the anal verge.
- Undergoing radical rectal cancer surgery with protective loop ileostomy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Able to understand the study procedures and willing to provide written informed consent.
Exclusion Criteria:
- History of inflammatory bowel disease, bacterial colitis, or other preoperative colonic inflammatory disease.
- Requirement for emergency surgery due to intestinal obstruction, perforation, bleeding, or other emergency conditions.
- Pregnant or lactating women.
- Presence of clinically significant gut microbiota dysbiosis before enrollment, as judged by the investigator.
- Planned postoperative radiotherapy, chemotherapy, or chemoradiotherapy.
- Poor compliance, inability to tolerate the intervention, or judged by the investigator to be unsuitable for participation in this clinical study.
- Severe postoperative complications such as anastomotic leakage.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Autologous Fecal Microbiota Transplantation Group
Participants with rectal cancer who underwent radical rectal cancer surgery with protective loop ileostomy will receive autologous fecal microbiota transplantation before ileostomy reversal.
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Autologous fecal microbiota transplantation will be prepared from the participant's own fecal material collected from the ileostomy output.
Approximately 50 g of fecal material will be mixed with 100 mL sterile normal saline, homogenized, filtered through sterile sieves, and administered slowly into the distal bowel via transanal catheter/enema.
The procedure will be performed once weekly at postoperative weeks 8, 9, 10, and 11, for a total of four administrations.
Participants will be observed after the procedure according to the study protocol.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Low Anterior Resection Syndrome Score at 3 Months After Ileostomy Reversal
기간: 3 months after ileostomy reversal
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Low Anterior Resection Syndrome (LARS) score will be assessed using the LARS questionnaire at 3 months after ileostomy reversal.
The total score ranges from 0 to 42 points, with higher scores indicating more severe bowel dysfunction.
Scores of 0-20 indicate no LARS, 21-29 indicate minor LARS, and 30-42 indicate major LARS.
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3 months after ileostomy reversal
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Colonoscopic Mucosal Findings Before Ileostomy Reversal
기간: Approximately 12 weeks after initial surgery and before ileostomy reversal
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The distal bowel mucosa will be evaluated by colonoscopy before ileostomy reversal.
Findings related to diversion colitis, including mucosal erythema, edema, friability, erosion, ulceration, bleeding, and mucus retention, will be recorded.
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Approximately 12 weeks after initial surgery and before ileostomy reversal
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- PKUPH-FMT-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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