Phase
Condition
N/ATreatment
Pooled allogeneic fecal microbiotherapy
Placebo
Clinical Study ID
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 50 years old
Presence of a hematologic malignancy for which an alloHCT is indicated with areduced toxicity or reduced intensity conditioning regimen
Patients with polynuclear neutrophils > 0.5 G/L
Patients having received wide spectrum antibiotics within the last 90 days prior toinclusion
Karnofsky index ≥ 70%
Availability of a sibling donor, an unrelated stem-cell donor or a familialhaploidentical donor
Written informed consent
Exclusion
Exclusion Criteria:
Patients planned to receive a non-myeloablative conditioning regimen (2 Gray totalbody irradiation (TBI) +/- purine analog, fludarabine + cyclophosphamide orequivalent)
Patients planned to receive a conventional myeloablative conditioning regimen (e.g.high dose cyclophosphamide and high dose TBI (≥10Gy); high dose busulfan (12.8 mg/kgIV) + high dose cyclophosphamide)
Patients receiving a manipulated graft (in-vitro T-cell depletion)
Patients planned to receive a conditioning regimen with alemtuzumab
Patients planned to receive alloHCT with cord blood cells
Patients planned to receive alloHCT from unrelated donor with >= 3/10 HLA-mismatches
Patients receiving a large spectrum antibiotic at time of randomization
Patients planned to receive vedolizumab or abatacept for GvHD prophylaxis
Creatinine clearance <30 mL/min
Bilirubin or amino-transferases abnormalities contra-indicating alloHCT
Cardiac ejection fraction less than 40%
Pulmonary impairment with <50% lung carbon monoxide diffusing capacity (DLCO)
Pregnancy
Confirmed or suspected intestinal ischemia
Confirmed or suspected toxic megacolon or gastrointestinal perforation
Any history of gastro-intestinal surgery in the past 3 months
Any history of chronic digestive disease (Crohn's disease, ulcerative colitis,inflammatory bowel disease or other relevant digestive condition according tophysician's judgement)
Known allergy or intolerance to trehalose or maltodextrin
Patients with EBV-IgG negative serology
Any condition that would, in the investigator's judgment, interfere with fullparticipation in the study, including administration of study drug and attendingrequired study visits; pose a significant risk to the subject; or interfere withinterpretation of study data.
Vulnerable patients such as: persons deprived of liberty, persons in Intensive CareUnit unable to provide informed consent prior to the intervention.
Study Design
Connect with a study center
Universitair Ziekenhuis Antwerpen
Antwerpen,
BelgiumActive - Recruiting
AZ Sint - Jan Brugge
Brugge,
BelgiumActive - Recruiting
Institut Jules Bordet
Brussel,
BelgiumActive - Recruiting
Universitair Ziekenhuis Brussel
Brussel,
BelgiumActive - Recruiting
Universitair Ziekenhuis Gent
Gent,
BelgiumActive - Recruiting
Cliniques Universitaires Saint-Luc
Louvain,
BelgiumActive - Recruiting
Algemeen Ziekenhuis Delta - Campus Rumbeke
Roeselare,
BelgiumActive - Recruiting
CHU Angers
Angers,
FranceActive - Recruiting
CHU Besançon
Besançon,
FranceActive - Recruiting
CHU Caen
Caen,
FranceActive - Recruiting
CHU Grenoble
La Tronche,
FranceActive - Recruiting
CHRU Lille
Lille,
FranceActive - Recruiting
Centre Hospitalier Universitaire Limoges
Limoges,
FranceActive - Recruiting
Institut Paoli Calmettes
Marseille,
FranceActive - Recruiting
Hôpital Saint-Eloi
Montpellier,
FranceActive - Recruiting
CHU Nantes Hôtel Dieu
Nantes,
FranceActive - Recruiting
Hôpital l'Archet
Nice,
FranceActive - Recruiting
Hôpital Saint-Louis
Paris,
FranceActive - Recruiting
Hôpital St Antoine
Paris,
FranceActive - Recruiting
Hôpital Haut-Lévêque
Pessac,
FranceActive - Recruiting
Centre Hospitalier Lyon-Sud
Pierre-Bénite,
FranceSite Not Available
Centre Hospitalier Universitaire de Poitiers
Poitiers,
FranceActive - Recruiting
CHU Rennes - Hôpital Pontchaillou
Rennes,
FranceActive - Recruiting
CHU St Etienne
Saint-Priest-en-Jarez,
FranceActive - Recruiting
IUCT Toulouse
Toulouse,
FranceActive - Recruiting
CHU Tours
Tours,
FranceActive - Recruiting
Centre Hospitalier Régional Universitaire de Tours
Tours,
FranceSite Not Available
Universitätsklinikum Augsburg
Augsburg,
GermanyActive - Recruiting
Helios Klinikum Berlin-Buch
Berlin,
GermanySite Not Available
Universitätsklinikum Bonn
Bonn,
GermanyActive - Recruiting
Universitätsklinikum Essen
Essen,
GermanySite Not Available
Universitätsklinikum Frankfurt
Frankfurt,
GermanySite Not Available
Universitätsklinikum des Saarlandes
Hombourg,
GermanyActive - Recruiting
Universitätsklinikum Schleswig-Holstein - Campus Kiel
Kiel,
GermanySite Not Available
Universitätsklinikum Leipzig
Leipzig,
GermanySite Not Available
Universitätsmedizin Mannheim
Mannheim,
GermanySite Not Available
Klinikum rechts der Isar der Technischen Universität
München,
GermanyActive - Recruiting
Universitätsklinikum Ulm
Ulm,
GermanyActive - Recruiting
Universitair Medisch Centrum Groningen
Groningen,
NetherlandsActive - Recruiting
Hospital Universitari Vall d'Hebrón
Barcelona,
SpainActive - Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona,
SpainActive - Recruiting
Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
Barcelona,
SpainActive - Recruiting
Hospital Universitario Virgen de las Nieves
Granada,
SpainActive - Recruiting
Hospital General Universitario Gregorio Marañón
Madrid,
SpainActive - Recruiting
Hospital Universitario La Paz
Madrid,
SpainActive - Recruiting
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda,
SpainActive - Recruiting
Hospital General Universitario Morales Meseguer
Murcia,
SpainActive - Recruiting
Clinica Universidad de Navarra - Pamplona
Pamplona,
SpainActive - Recruiting
Complejo Asistencial Universitario de Salamanca - Hospital Clínico
Salamanca,
SpainActive - Recruiting
Hospital Universitario Marques de Valdecilla
Santander,
SpainActive - Recruiting
Hospital Universitario Virgen del Rocío
Sevilla,
SpainActive - Recruiting
Hospital Clínico Universitario de Valencia Avenida Blasco Ibáñez
Valencia,
SpainActive - Recruiting
Hospital Universitario La Fe
Valencia,
SpainActive - Recruiting
Cardiff and Vale University Health Board
Cardiff,
United KingdomActive - Recruiting
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