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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Tel Aviv, Israël, 64239
- Recrutement
- Department of Gastroentherology
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Chercheur principal:
- Nitsan Maharshak, MD
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Sous-enquêteur:
- Naomi Fliss Isakov, PhD
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Contact:
- Nitsan Maharshak, MD
- Numéro de téléphone: 972-3-6972488
- E-mail: nitsanm@tlvmc.gov.il
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Sous-enquêteur:
- Nethaniel Aviv Cohen, MD
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Tel Aviv, Israël
- Recrutement
- Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
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Chercheur principal:
- Nitsan Maharshak, MD
-
Sous-enquêteur:
- Naomi Fliss Isakov, PhD
-
Contact:
- Nitsan Maharshak, MD
- Numéro de téléphone: 972-3-6947305
- E-mail: nitsanm@tlvmc.gov.il
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Sous-enquêteur:
- Nathaniel Aviv Cohen, MD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: 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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Comparateur placebo: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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safety of FMT pre vedolizumab treatment in CD patients
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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efficacy of FMT pre vedolizumab treatment in CD patients that results in clinical response rate
Délai: 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
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efficacy of FMT pre vedolizumab treatment in CD patients that results in clinical response rate
Délai: 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
Délai: 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
|
week 46
|
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efficacy of FMT pre vedolizumab treatment in CD patients that results in endoscopic response
Délai: 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
Délai: 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
Délai: 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
Délai: 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
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efficacy of FMT pre vedolizumab treatment in CD patients that results in biological remission
Délai: 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
|
week 22
|
|
efficacy of FMT pre vedolizumab treatment in CD patients that results in biological remission
Délai: 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
|
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safety of FMT pre vedolizumab treatment in CD patients that results in low adverse events rate
Délai: 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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Collaborateurs et enquêteurs
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Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- TASMC-16-NH-0123-CTIL
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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