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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100044
- Peking University People's Hospital
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Low Anterior Resection Syndrome Score at 3 Months After Ileostomy Reversal
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Colonoscopic Mucosal Findings Before Ileostomy Reversal
時間枠：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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- PKUPH-FMT-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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