Fecal Microbial Transplantation and Vedolizumab Treatment of Crohn's Disease
Fecal Microbial Transplantation for the Optimization of Vedolizumab Treatment in Patients With Crohn's Disease
The investigators postulate that by determining a patient's baseline microbiome and manipulating it through fecal microbial transplantation (FMT) may improve response rates to vedolizumab in Crohn's disease (CD) patients.
Primary objective: To determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is safe and results in higher remission rates in CD patients.
Study design: A randomized double blinded controlled clinical trial. Study population:CD patients 18-65 YO, men and women, with mild-moderately active disease determined by the Harvey-Bradshaw index (HBI) of 5≤HBI≤15, who were found eligible to commence treatment with vedolizumab.
Study procedure: Study participants will receive FMT within a week prior to first vedolizumab infusion.
All patients will be followed for 46 weeks in 8 visits at the IBD clinic in the GI department of the Tel Aviv Medical Center.
調査の概要
詳細な説明
Study design: A randomized double blinded controlled clinical trial.
Study population:
CD patients 18-65 YO, men and women, with mild-moderately active disease determined by the Harvey-Bradshaw index (HBI) of 5≤HBI≤15, who were found eligible to commence treatment with vedolizumab (screened for tuberculosis and hepatitis B and without an active infection or an abscess) will be enrolled in the study.
Follow-up: All patients will be followed by physician assessment, sample collection, anthropometric measurements and questionnaires during the scheduled visits at weeks 2, 6, 14, 22, and at week 46, on which they will undergo a colonoscopic examination as part of their regular clinical followup.
Side effects (SE): will be monitored by phone, 3 days post intervention and at vedolizumab infusion visits at weeks 2 and 6. Also, patients will receive direct contact details of both the study coordinator and the study PI.
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
研究場所
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-
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Tel Aviv、イスラエル、64239
- 募集
- Department of Gastroentherology
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主任研究者：
- Nitsan Maharshak, MD
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副調査官：
- Naomi Fliss Isakov, PhD
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コンタクト：
- Nitsan Maharshak, MD
- 電話番号：972-3-6972488
- メール：nitsanm@tlvmc.gov.il
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副調査官：
- Nethaniel Aviv Cohen, MD
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Tel Aviv、イスラエル
- 募集
- Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
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主任研究者：
- Nitsan Maharshak, MD
-
副調査官：
- Naomi Fliss Isakov, PhD
-
コンタクト：
- Nitsan Maharshak, MD
- 電話番号：972-3-6947305
- メール：nitsanm@tlvmc.gov.il
-
副調査官：
- Nathaniel Aviv Cohen, MD
-
-
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:
- Mild-moderately active disease determined by the Harvey-Bradshaw index (HBI) of 5≤HBI≤15
- Found eligible to commence treatment with vedolizumab (screened for tuberculosis and hepatitis B and without an active infection or an abscess)
Exclusion Criteria:
- CD patients in remission (HBI<5) or with sever disease (HBI>16)
- Patients with a stoma
- Hospitalized patients
- Patients with an active intestinal infection- positive stool culture or Clostridium difficile infection
- Severe disease - malignant disease, hepatic failure, renal failure, cardiovascular, metabolic, neurological disease
- Pregnant/lactating women
- Inability to sign an informed consent
- Inability to complete the study protocol
- An ongoing or planned antibiotics therapy
- Severe food allergies
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Fecal microbial transplantation
FMT capsules fecal capsules on two consecutive days (total of 30 capsules) within a week prior to first vedolizumab infusion.
Patients who will be allocated to this treatment arm will be matched to donors according to their CMV status (past exposure - CMV positive donors will be used for CMV positive patients, and CMV negative donors will be used for CMV negative patients).
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Capsules of fecal matter solution (feces from healthy donor, glycerol and saline solution)/
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プラセボコンパレーター：Placebo
Placebo capsules placebo capsules- on two consecutive days (total of 30 capsules) within a week prior to first vedolizumab infusion.
Patients who will be allocated to this treatment arm will receive placebo capsules.
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capsules of glycerol and saline (placebo).
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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 |
|---|---|---|
|
safety of FMT pre vedolizumab treatment in CD patients
時間枠：week 14
|
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is safe. safety of FMT will be measured by disease exacerbations, hospitalizations and surgery rate in treatment versus placebo group. |
week 14
|
|
safety of FMT pre vedolizumab treatment in CD patients: measured by disease exacerbations, hospitalizations and surgery rate in treatment versus placebo group
時間枠：week 46
|
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is safe. safety of FMT will be measured by disease exacerbations, hospitalizations and surgery rate in treatment versus placebo group. |
week 46
|
|
efficacy of FMT pre vedolizumab treatment in CD patients that results in higher remission rate
時間枠：week 14
|
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in higher remission rates in CD patients. Remission rate will be measured by clinical remission rate HBI ≤5 at week 14 |
week 14
|
|
efficacy of FMT pre vedolizumab treatment in CD patients that results in higher remission rate
時間枠：week 46
|
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in higher remission rates in CD patients. Remission rate will be measured by clinical remission rate HBI ≤5 at week 46 |
week 46
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
efficacy of FMT pre vedolizumab treatment in CD patients that results in clinical response rate
時間枠：week 14
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determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in clinical response rate (reduction in HBI≥3 )
|
week 14
|
|
efficacy of FMT pre vedolizumab treatment in CD patients that results in clinical response rate
時間枠：week 22
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determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in reduction in HBI≥3
|
week 22
|
|
efficacy of FMT pre vedolizumab treatment in CD patients that results in clinical response rate
時間枠：week 46
|
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in reduction in HBI≥3
|
week 46
|
|
efficacy of FMT pre vedolizumab treatment in CD patients that results in endoscopic response
時間枠：week 46
|
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in endoscopic response that will be defined as a decrease of ≥50% in SES-CD score / improvement in Rutgeerts score ≥1, compared to baseline colonoscopy
|
week 46
|
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efficacy of FMT pre vedolizumab treatment in CD patients that results in endoscopic remission
時間枠：week 46
|
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in Endoscopic remission at week 46 will be defined as SES-CD ≤2 or Rutgeerts score ≤1 , compared to baseline colonoscopy
|
week 46
|
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efficacy of FMT pre vedolizumab treatment in CD patients that results in histological healing
時間枠：week 46
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determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in histological healing compared to week 0
|
week 46
|
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efficacy of FMT pre vedolizumab treatment in CD patients that results in biological remission
時間枠：week 14
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determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in biological remission measured as fecal calprotectin<150mg/kg and CRP<5mg/L
|
week 14
|
|
efficacy of FMT pre vedolizumab treatment in CD patients that results in biological remission
時間枠：week 22
|
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in biological remission measured as fecal calprotectin<150mg/kg and CRP<5mg/L
|
week 22
|
|
efficacy of FMT pre vedolizumab treatment in CD patients that results in biological remission
時間枠：week 46
|
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in biological remission measured as fecal calprotectin<150mg/kg and CRP<5mg/L
|
week 46
|
|
safety of FMT pre vedolizumab treatment in CD patients that results in low adverse events rate
時間枠：week 46
|
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is safe and results in lower adverse events rate of intervention versus placebo
|
week 46
|
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 (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
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