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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Tel Aviv, Israël, 64239
- Werving
- Department of Gastroentherology
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Hoofdonderzoeker:
- Nitsan Maharshak, MD
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Onderonderzoeker:
- Naomi Fliss Isakov, PhD
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Contact:
- Nitsan Maharshak, MD
- Telefoonnummer: 972-3-6972488
- E-mail: nitsanm@tlvmc.gov.il
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Onderonderzoeker:
- Nethaniel Aviv Cohen, MD
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Tel Aviv, Israël
- Werving
- Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
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Hoofdonderzoeker:
- Nitsan Maharshak, MD
-
Onderonderzoeker:
- Naomi Fliss Isakov, PhD
-
Contact:
- Nitsan Maharshak, MD
- Telefoonnummer: 972-3-6947305
- E-mail: nitsanm@tlvmc.gov.il
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Onderonderzoeker:
- Nathaniel Aviv Cohen, MD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: 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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Placebo-vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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safety of FMT pre vedolizumab treatment in CD patients
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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efficacy of FMT pre vedolizumab treatment in CD patients that results in clinical response rate
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
|
efficacy of FMT pre vedolizumab treatment in CD patients that results in endoscopic response
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Studie record data
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Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
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Laatste update ingediend die voldeed aan QC-criteria
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- TASMC-16-NH-0123-CTIL
Plan Individuele Deelnemersgegevens (IPD)
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