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Fecal Microbial Transplantation and Vedolizumab Treatment of Crohn's Disease

31. marts 2020 opdateret af: michal roll, Tel-Aviv Sourasky Medical Center

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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Israel
      • Tel Aviv, Israel, 64239
        • Rekruttering
        • Department of Gastroentherology
        • Ledende efterforsker:
          • Nitsan Maharshak, MD
        • Underforsker:
          • Naomi Fliss Isakov, PhD
        • Kontakt:
        • Underforsker:
          • Nethaniel Aviv Cohen, MD
      • Tel Aviv, Israel
        • Rekruttering
        • Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
        • Ledende efterforsker:
          • Nitsan Maharshak, MD
        • Underforsker:
          • Naomi Fliss Isakov, PhD
        • Kontakt:
        • Underforsker:
          • Nathaniel Aviv Cohen, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Mild-moderately active disease determined by the Harvey-Bradshaw index (HBI) of 5≤HBI≤15
  2. Found eligible to commence treatment with vedolizumab (screened for tuberculosis and hepatitis B and without an active infection or an abscess)

Exclusion Criteria:

  1. CD patients in remission (HBI<5) or with sever disease (HBI>16)
  2. Patients with a stoma
  3. Hospitalized patients
  4. Patients with an active intestinal infection- positive stool culture or Clostridium difficile infection
  5. Severe disease - malignant disease, hepatic failure, renal failure, cardiovascular, metabolic, neurological disease
  6. Pregnant/lactating women
  7. Inability to sign an informed consent
  8. Inability to complete the study protocol
  9. An ongoing or planned antibiotics therapy
  10. Severe food allergies

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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).
Andet: Fecal microbial transplantation
Capsules of fecal matter solution (feces from healthy donor, glycerol and saline solution)/
Placebo komparator: 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.
Andet: Placebo capsuls
capsules of glycerol and saline (placebo).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
safety of FMT pre vedolizumab treatment in CD patients
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
efficacy of FMT pre vedolizumab treatment in CD patients that results in clinical response rate
Tidsramme: week 14
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
Tidsramme: week 22
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
Tidsramme: 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
Tidsramme: 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
efficacy of FMT pre vedolizumab treatment in CD patients that results in endoscopic remission
Tidsramme: 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
efficacy of FMT pre vedolizumab treatment in CD patients that results in histological healing
Tidsramme: week 46
determine whether manipulation of gut microbiome by FMT pre vedolizumab treatment is efficient and results in histological healing compared to week 0
week 46
efficacy of FMT pre vedolizumab treatment in CD patients that results in biological remission
Tidsramme: week 14
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tel-Aviv Sourasky Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

3. juli 2018

Primær færdiggørelse (Forventet)

1. april 2022

Studieafslutning (Forventet)

1. januar 2023

Datoer for studieregistrering

Først indsendt

8. februar 2019

Først indsendt, der opfyldte QC-kriterier

31. marts 2020

Først opslået (Faktiske)

1. april 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. april 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. marts 2020

Sidst verificeret

1. marts 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TASMC-16-NH-0123-CTIL

Plan for individuelle deltagerdata (IPD)

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