Safety and Efficacy of Heterologous FMT by SQIMC-md Capsule in Mild-moderate Ulcerative Colitis Patients (SQIMC-md)
Safety and Efficacy of Heterologous Fecal Microbiota Transplantation (FMT) by Standardized Quantitative Multi-donor Intestinal Microbiota Capsule (SQIMC-md) in Mild-moderate Ulcerative Colitis Patients-a Multi-center Double-blind RCT Trial
調査の概要
状態
条件
詳細な説明
All candidates for mild-moderate ulcerative colitis treated in Dept. Gastroenterology, Tongji Hospital, Tongji Medical College of HUST, the second Xiangya Hospital of central south university and the first affiliated Hospital of Zhengzhou University will be screened for study inclusion and exclusion criteria. All consenting patients will 2:1 randomized into SQIMC-md treatment group or Placebo group. Three dose of SQIMC-md capsule will be orally administrated on day1, day2 and day3. Follow-up will be performed every 4 weeks and last for 12weeks. Full dose of 5-ASA is orally administrated simultaneously during the study. Clinical data and outcome will be collected and documented in electronic case reported form (eCRF).
FMT DONORS:
Potential healthy adult stool donors (between 18 and 28 years of age) will be recruited by the research staff. They will be asked to volunteer for the screening and regularly supply stool samples according to the study protocol.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Fang Xiao, Doctoral
- 電話番号：008615927368783
- メール：christina_fx@126.com
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patients must have a diagnosis of ulcerative colitis based on clinical symptoms, as well as laboratory and colonoscopic findings, including histopathologic results of the intestinal mucosa.
- Ulcerative Colitis complete Mayo score range from 4 to 10 [mild-moderate activity] and Mayo endoscopic score ≥2 as assessed within 4 weeks prior to enrollment and clinical symptoms that are at least stable.
- Patients failed to acquire clinical remission after full dose and adequate course (4 weeks) of 5-ASA or precursors treatment.
- Patients ≥ 18 and < 70 years of age are eligible for this trial.
- All patients must sign a written informed consent document. Assent, when appropriate, will be obtained according to institutional guidelines.
Exclusion Criteria:
- Human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) or other severe immunodeficiency
- Patients with severe prior allergic reaction to food or supplementary material of placebo will be excluded from the protocol.
- Patients who are pregnant or lactating will be excluded from the protocol.
- Suspected as CMV or EBV colitis by endoscopic findings and proved by immunohistochemistry and biopsy PCR.
- Decompensated life-threatening disease including but not restricted to liver cirrhosis (bleeding varices, ascites, encephalopathy or icterus), heart attack, malignancy and so on.
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：Placebo capsule arm
Oral administration of 30 placebo capsule containing edible pigmented starch together with full dose of oral 5-Aminosalicylic acid(5-ASA).
|
Oral administration of 30 placebo capsule containing edible pigmented starch
|
|
アクティブコンパレータ：SQIMC-md FMT arm
Oral administration of 30 SQIMC-md capsules containing 2*10^13 copies of prepared fecal microbiota lyophilized powder from multiple healthy donors' fresh feces together with full dose of oral 5-Aminosalicylic acid(5-ASA).
|
heterologous fecal microbiota transplantation (FMT) by Standardized Quantitative multi-donor Intestinal Microbiota Capsule (SQIMC-md)
|
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 |
|---|---|---|
|
Clinical response rate at week 8 after SQIMC-md treatment.
時間枠：8 weeks
|
Assess efficacy of SQIMC-md FMT treatment with the aid of the Mayo score for Ulcerative Colitis clinical disease severity and response rate at week 8 after SQIMC-md treatment. Mayo score (Disease activity index) for Ulcerative Colitis. Total range for complete Mayo score 0-12 (sum from 4 subscales below) and partial Mayo score 0-9 (sum from 1,2 and 4 subscales below): Each subscale for mayo score:
Clinical response rate is defined as a decrease of ≥ 3 points and at least 30% from baseline in the Mayo score, with an accompanying decrease of ≥ 1 point in the subscore for rectal bleeding or an absolute subscore ≤ 1 for rectal bleeding |
8 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events
時間枠：12 weeks
|
safety of SQIMC-md FMT treatment by recording the incidence of adverse events.
|
12 weeks
|
|
clinical response rate at week4 and week12
時間枠：week4 and week12
|
Assess the efficacy of SQIMC-md FMT by response rate at week4 and week12
|
week4 and week12
|
|
the remission rate at week12
時間枠：12 weeks
|
the remission rate at week12 with the aid of mayo score or partial Mayo score.
Clinical remission rate at week 12 after treatment (clinical remission is defined as a Mayo score of ≤ 2 points and no single score > 1 point
|
12 weeks
|
|
Mean (or median) decrease of fecal calprotectin
時間枠：12 weeks
|
Assess the efficacy of SQIMC-md FMT measured by the drop of fecal calprotectin.
|
12 weeks
|
|
Mean (or median) change from baseline in Inflammatory Bowel Disease Questionnaire （IBDQ） total score and subscore at week 12
時間枠：12 weeks
|
IBDQ includes 32 questions.
The questions are grouped into four categories (subscore): Bowel symptoms (B), Systemic symptoms (S), Emotional function (E) and Social function (SF).
Response options are consistently presented as seven-point scales (1-7).
Total score is defined as the sum of subscore of four categories.
|
12 weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Fang Xiao, Doctoral、Tongji Hospital
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
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
その他の研究ID番号
- 2019CR209
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
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- ICF
- CSR
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
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。
placebo capsuleの臨床試験
-
Bin CaoBeijing Chest Hospital; China-Japan Friendship Hospital; Shanghai Pulmonary Hospital, Shanghai... と他の協力者募集
-
Shanghai Hengrui Pharmaceutical Co., Ltd.完了
-
Guangdong Hengrui Pharmaceutical Co., Ltd募集
-
Consano Bio募集坐骨神経痛 | 坐骨神経根症 | 腰仙神経根症 | 腰仙神経根症候群 | 腰仙部神経根痛 | 坐骨神経痛オーストラリア