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Fecal Microbial Transplantation and Vedolizumab Treatment of Crohn's Disease

31. März 2020 aktualisiert von: 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.

Studienübersicht

Status

Unbekannt

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

80

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver 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).
Sonstiges: 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.
Sonstiges: Placebo capsuls
capsules of glycerol and saline (placebo).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
safety of FMT pre vedolizumab treatment in CD patients
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
efficacy of FMT pre vedolizumab treatment in CD patients that results in clinical response rate
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Tel-Aviv Sourasky Medical Center

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

3. Juli 2018

Primärer Abschluss (Voraussichtlich)

1. April 2022

Studienabschluss (Voraussichtlich)

1. Januar 2023

Studienanmeldedaten

Zuerst eingereicht

8. Februar 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

31. März 2020

Zuerst gepostet (Tatsächlich)

1. April 2020

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. April 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

31. März 2020

Zuletzt verifiziert

1. März 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • TASMC-16-NH-0123-CTIL

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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