Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Fecal Microbial Transplantation and Vedolizumab Treatment of Crohn's Disease

31 mars 2020 uppdaterad av: 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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

80

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Israel
      • Tel Aviv, Israel, 64239
        • Rekrytering
        • Department of Gastroentherology
        • Huvudutredare:
          • Nitsan Maharshak, MD
        • Underutredare:
          • Naomi Fliss Isakov, PhD
        • Kontakt:
        • Underutredare:
          • Nethaniel Aviv Cohen, MD
      • Tel Aviv, Israel
        • Rekrytering
        • Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
        • Huvudutredare:
          • Nitsan Maharshak, MD
        • Underutredare:
          • Naomi Fliss Isakov, PhD
        • Kontakt:
        • Underutredare:
          • Nathaniel Aviv Cohen, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / 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).
Övrig: Fecal microbial transplantation
Capsules of fecal matter solution (feces from healthy donor, glycerol and saline solution)/
Placebo-jämförare: 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.
Övrig: Placebo capsuls
capsules of glycerol and saline (placebo).

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
safety of FMT pre vedolizumab treatment in CD patients
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
efficacy of FMT pre vedolizumab treatment in CD patients that results in clinical response rate
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Tel-Aviv Sourasky Medical Center

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

3 juli 2018

Primärt slutförande (Förväntat)

1 april 2022

Avslutad studie (Förväntat)

1 januari 2023

Studieregistreringsdatum

Först inskickad

8 februari 2019

Först inskickad som uppfyllde QC-kriterierna

31 mars 2020

Första postat (Faktisk)

1 april 2020

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 april 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

31 mars 2020

Senast verifierad

1 mars 2020

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • TASMC-16-NH-0123-CTIL

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Crohns sjukdom

Kliniska prövningar på Fecal microbial transplantation

Sök liknande försök

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

CROs by country

CROs in Italy

Betingelser

Sällsynta sjukdomar

Läkemedelsinterventioner

Kosttillskott

Sponsor / medarbetare

Platser

3
Prenumerera