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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Tel Aviv, Israel, 64239
- Reclutamiento
- Department of Gastroentherology
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Investigador principal:
- Nitsan Maharshak, MD
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Sub-Investigador:
- Naomi Fliss Isakov, PhD
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Contacto:
- Nitsan Maharshak, MD
- Número de teléfono: 972-3-6972488
- Correo electrónico: nitsanm@tlvmc.gov.il
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Sub-Investigador:
- Nethaniel Aviv Cohen, MD
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Tel Aviv, Israel
- Reclutamiento
- Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
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Investigador principal:
- Nitsan Maharshak, MD
-
Sub-Investigador:
- Naomi Fliss Isakov, PhD
-
Contacto:
- Nitsan Maharshak, MD
- Número de teléfono: 972-3-6947305
- Correo electrónico: nitsanm@tlvmc.gov.il
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Sub-Investigador:
- Nathaniel Aviv Cohen, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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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Comparador de placebos: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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safety of FMT pre vedolizumab treatment in CD patients
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: week 14
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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
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efficacy of FMT pre vedolizumab treatment in CD patients that results in higher remission rate
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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efficacy of FMT pre vedolizumab treatment in CD patients that results in clinical response rate
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- TASMC-16-NH-0123-CTIL
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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