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.
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Tel Aviv, 이스라엘, 64239
- 모병
- Department of Gastroentherology
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수석 연구원:
- Nitsan Maharshak, MD
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부수사관:
- Naomi Fliss Isakov, PhD
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연락하다:
- Nitsan Maharshak, MD
- 전화번호: 972-3-6972488
- 이메일: nitsanm@tlvmc.gov.il
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부수사관:
- Nethaniel Aviv Cohen, MD
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Tel Aviv, 이스라엘
- 모병
- Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
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수석 연구원:
- Nitsan Maharshak, MD
-
부수사관:
- Naomi Fliss Isakov, PhD
-
연락하다:
- Nitsan Maharshak, MD
- 전화번호: 972-3-6947305
- 이메일: nitsanm@tlvmc.gov.il
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부수사관:
- Nathaniel Aviv Cohen, MD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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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위약 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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safety of FMT pre vedolizumab treatment in CD patients
기간: week 14
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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
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safety of FMT pre vedolizumab treatment in CD patients: measured by disease exacerbations, hospitalizations and surgery rate in treatment versus placebo group
기간: week 46
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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
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efficacy of FMT pre vedolizumab treatment in CD patients that results in higher remission rate
기간: 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
기간: 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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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efficacy of FMT pre vedolizumab treatment in CD patients that results in clinical response rate
기간: 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 )
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week 14
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efficacy of FMT pre vedolizumab treatment in CD patients that results in clinical response rate
기간: 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
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week 22
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efficacy of FMT pre vedolizumab treatment in CD patients that results in clinical response rate
기간: week 46
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determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in reduction in HBI≥3
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week 46
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efficacy of FMT pre vedolizumab treatment in CD patients that results in endoscopic response
기간: week 46
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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
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week 46
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efficacy of FMT pre vedolizumab treatment in CD patients that results in endoscopic remission
기간: week 46
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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
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week 46
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efficacy of FMT pre vedolizumab treatment in CD patients that results in histological healing
기간: 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
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week 46
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efficacy of FMT pre vedolizumab treatment in CD patients that results in biological remission
기간: 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
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week 14
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efficacy of FMT pre vedolizumab treatment in CD patients that results in biological remission
기간: week 22
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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
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week 22
|
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efficacy of FMT pre vedolizumab treatment in CD patients that results in biological remission
기간: week 46
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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
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week 46
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safety of FMT pre vedolizumab treatment in CD patients that results in low adverse events rate
기간: week 46
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determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is safe and results in lower adverse events rate of intervention versus placebo
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week 46
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
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 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
크론병에 대한 임상 시험
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L2 Bio, LLCFDAMap; Akan Biosciences, Inc.아직 모집하지 않음Crohn & amp;#39; s | Crohn & amp;#39; s Disease (CD)
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Vanderbilt University Medical CenterTakeda Pharmaceuticals U.S.A., Inc.모집하지 않고 적극적으로염증성 장질환(IBD) | 궤양성 대장염(UC) | Crohn & amp;#39; s Disease (CD)미국
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Azienda Ospedaliera Ordine Mauriziano di Torino완전한
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Region SkaneLund University; Linkoeping University; Malmö University모병
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Nova Scotia Health Authority아직 모집하지 않음
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Shanghai 10th People's Hospital모집하지 않고 적극적으로분변 미생물 이식 | 염증성 장 질환 (Crohn & amp;#39; s 질병 및 궤양 성 대장염)중국
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Raincy Montfermeil Hospital GroupJanssen Cilag S.A.S.모병염증성 장질환(IBD) | 염증성 장 질환 (Crohn & amp;#39; s 질병 및 궤양 성 대장염)프랑스
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Kaohsiung Medical University아직 모집하지 않음폐 선암종 | 폐암(진단) | Condition/Disease
Fecal microbial transplantation에 대한 임상 시험
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Assistance Publique - Hôpitaux de Paris아직 모집하지 않음
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UMC UtrechtZimmer Biomet초대로 등록