Fecal Microbiota Transplantation for Ulcerative Colitis Using Dai and Han Donors
Fecal Microbiota Transplantation for Ulcerative Colitis Using Healthy Donors From Yunnan Dai and Han Nationalities: A Randomized Study to Screen Core Metabolites and Key Microbiota
This study is a randomized clinical trial evaluating fecal microbiota transplantation (FMT) for ulcerative colitis (UC) using healthy donors from two ethnic groups in Yunnan, China. UC is a chronic inflammatory bowel disease causing colon inflammation and ulcers. FMT transfers gut bacteria from a healthy donor to a patient to restore healthy intestinal microbiota.
Previous research suggested that FMT using donors from the Dai ethnic group (a minority nationality in Yunnan with special dietary habits) may achieve better results than Han Chinese donors for UC. This study aims to confirm this finding and understand why.
The investigators will recruit 200 UC patients (ages 18-60) and randomly assign them to two groups (100 each). One group will receive FMT from healthy Han donors; the other from healthy Dai donors. Patients will receive three FMT infusions via endoscopic intestinal tubing. Treatment effects will be assessed at 12 weeks using clinical scores (Mayo score), endoscopic scores (MES), inflammatory markers (fecal calprotectin, CRP, ESR), and intestinal barrier function tests.
Stool samples will also be analyzed using metabolomics and metagenomics to identify key gut bacteria and metabolites linked to better outcomes, and laboratory experiments will be performed to verify how they reduce intestinal inflammation.
The goal is to identify optimal donor characteristics for FMT in UC and uncover mechanisms that may lead to more personalized microbiota therapies.
調査の概要
詳細な説明
This randomized, parallel-group clinical study investigates the efficacy and mechanisms of fecal microbiota transplantation (FMT) using healthy donors from the Dai nationality versus Han nationality for treating ulcerative colitis (UC).
Background: UC is a chronic relapsing inflammatory bowel disease characterized by colonic mucosal inflammation. FMT has emerged as a promising therapeutic strategy by reconstructing intestinal microbiota. Preliminary findings indicate that FMT using donors from the Dai ethnic group in Yunnan Province (who have unique dietary and lifestyle habits) may achieve superior clinical remission compared to Han donors. This study aims to validate this observation and identify the core metabolites and key gut microbiota responsible for the enhanced efficacy.
Study Design: A total of 200 UC patients (aged 18-60 years, Mayo score 3-10, left-sided colitis) will be enrolled and randomly allocated into two groups (n=100 each): (1) FMT with healthy Han donors; (2) FMT with healthy Dai donors. Donors will be healthy individuals aged 18-23 years screened according to AGA guidelines.
Intervention: Patients will receive FMT via transendoscopic enteral tubing (TET) at 60 mL per infusion, once every 3 days for a total of 3 times.
Outcome Measures: Primary efficacy is clinical remission at week 12 (Mayo total score ≤2, no individual subscore >1, endoscopic subscore decreased by ≥1 from baseline). Secondary endpoints include Mayo score, MES, histopathology (HE staining), fecal calprotectin, CRP, ESR, and intestinal mucosal barrier function.
Mechanistic Investigations: Donor and recipient stool samples will be collected before FMT and at weeks 1 and 12 post-FMT. Metabolomics (LC-MS/MS, GC-MS) and metagenomic sequencing will identify differential metabolites and key bacterial taxa. Co-occurrence and metabolic complementarity networks will identify keystone species. Correlation analysis will reveal functional microbial groups. In vitro and in vivo experiments will validate the anti-inflammatory effects of identified key bacteria and metabolites.
Significance: This study will elucidate why Dai donors may confer superior FMT outcomes and identify transplantable microbial signatures and bioactive metabolites for UC therapy.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Zihong Chen
- 電話番号：+86 18388452165
- メール：chenzihong2018@163.com
研究場所
-
-
Yunnan
-
Kunming、Yunnan、中国、650032
- 募集
- Kunming Medical University First Affiliated Hospital
-
コンタクト：
- Zihong Chen, MD
-
主任研究者：
- Yinglei Miao, MD
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age 18-60 years
- Diagnosed with ulcerative colitis (left-sided colitis) according to ECCO guidelines and Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (2023 Xi'an)
- Baseline Mayo score 3-10
- Treated only with mesalazine before and during the study to exclude drug interference
Exclusion Criteria:
- Pregnancy or planned pregnancy in the near future
- Patients in clinical remission (Mayo score ≤2 with no individual subscore >1)
- Development of diseases different from or confounding the initial diagnosis during the study
- History of toxic megacolon, perianal disease, or intestinal surgery
- Concurrent severe cardiac, pulmonary, or renal disease, or malignancy
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：ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
|
実験的：Han Donor FMT Group
Patients with ulcerative colitis (UC) receive fecal microbiota transplantation (FMT) from healthy Han donors aged 18-23 years.
FMT is administered via transendoscopic enteral tubing (TET) at 60 mL per session, once every 3 days, for a total of 3 sessions.
Only mesalazine is used before and after FMT to exclude drug interference.
Clinical efficacy will be evaluated at 12 weeks post-FMT.
|
Donor stool (60 g) is processed using the CleanFMT method with GenFMTer system, including filtration, centrifugation, washing, and resuspension in sterile normal saline (1.5× volume).
The final product is 200 mL fecal suspension, administered via TET at 60 mL per session, once every 3 days, for 3 sessions total.
他の名前：
|
|
実験的：Dai Donor FMT Group
Patients with ulcerative colitis (UC) receive fecal microbiota transplantation (FMT) from healthy Dai donors aged 18-23 years from Xishuangbanna, Yunnan.
FMT is administered via transendoscopic enteral tubing (TET) at 60 mL per session, once every 3 days, for a total of 3 sessions.
Only mesalazine is used before and after FMT to exclude drug interference.
Clinical efficacy will be evaluated at 12 weeks post-FMT.
|
Donor stool (60 g) is processed using the CleanFMT method with GenFMTer system, including filtration, centrifugation, washing, and resuspension in sterile normal saline (1.5× volume).
The final product is 200 mL fecal suspension, administered via TET at 60 mL per session, once every 3 days, for 3 sessions total.
他の名前：
|
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 |
|---|---|---|
|
Rate of clinical and endoscopic remission at 12 weeks
時間枠：12 weeks after the first FMT session
|
Proportion of ulcerative colitis patients achieving both clinical and endoscopic remission at 12 weeks after fecal microbiota transplantation (FMT) without corticosteroid use.
Clinical remission is defined as a total Mayo score ≤2 with no individual subscore >1.
Endoscopic improvement is defined as a decrease in the Mayo Endoscopic Subscore (MES) of at least 1 point from baseline.
Patients must achieve both criteria simultaneously.
|
12 weeks after the first FMT session
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mayo Score
時間枠：Baseline (1 day pre-FMT), 1 week, and 12 weeks post-FMT
|
Change from baseline in total Mayo score (range 0-12, higher scores indicate more severe disease activity).
|
Baseline (1 day pre-FMT), 1 week, and 12 weeks post-FMT
|
|
Mayo Endoscopic Subscore (MES)
時間枠：Baseline and 12 weeks post-FMT
|
Change from baseline in MES (range 0-3, where 0=normal/remission, 1=mild, 2=moderate, 3=severe).
|
Baseline and 12 weeks post-FMT
|
|
Histopathological Assessment by HE Staining
時間枠：Baseline and 12 weeks post-FMT
|
Histological changes in colonic mucosal biopsies assessed by HE staining.
|
Baseline and 12 weeks post-FMT
|
|
Fecal Calprotectin
時間枠：Baseline, 1 week, and 12 weeks post-FMT
|
Change from baseline in fecal calprotectin levels as a marker of intestinal inflammation.
|
Baseline, 1 week, and 12 weeks post-FMT
|
|
C-Reactive Protein (CRP)
時間枠：Baseline, 1 week, and 12 weeks post-FMT
|
Change from baseline in serum CRP levels.
|
Baseline, 1 week, and 12 weeks post-FMT
|
|
Erythrocyte Sedimentation Rate (ESR)
時間枠：Baseline, 1 week, and 12 weeks post-FMT
|
Change from baseline in ESR.
|
Baseline, 1 week, and 12 weeks post-FMT
|
|
Intestinal Mucosal Barrier Function
時間枠：Baseline and 12 weeks post-FMT
|
Assessment of intestinal mucosal barrier function in UC patients after FMT.
|
Baseline and 12 weeks post-FMT
|
協力者と研究者
捜査官
- 主任研究者：Yinglei Miao, MD、Kunming Medical University First Affiliated Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。