RecruitingPhase 2NCT05762211

Oral Pooled Fecal Microbiotherapy to Prevent Allogeneic Hematopoietic Cell Transplantation Complications (PHOEBUS Trial)

A Multi-center Randomized, Double Blinded Phase IIb Trial Evaluating Oral Pooled Fecal Microbiotherapy MaaT033 to Prevent Allogeneic Hematopoietic Cell Transplantation Complications (PHOEBUS Trial)

Sponsor

MaaT Pharma

Enrollment

387 participants

Start Date

Oct 31, 2023

Study Type

INTERVENTIONAL

Conditions

Transplant Complication

Summary

This randomized, placebo-controlled phase IIb study (PHOEBUS trial) aims to evaluate the activity of fecal microbiotherapy MaaT033 to improve survival through the prevention of transplant-related complications in eligible alloHCT patients

Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This trial — PHOEBUS — is testing whether giving patients oral fecal microbiotherapy (essentially a carefully processed oral capsule containing fecal microbiota from healthy donors) before allogeneic hematopoietic cell transplantation (alloHCT) can reduce serious complications. AlloHCT is a bone marrow transplant from a donor, used to treat blood cancers like leukemia and lymphoma. One of its most dangerous complications is graft-versus-host disease (GvHD), where the donor's immune cells attack the recipient's organs, particularly the gut. The gut microbiome appears to play a crucial role in this process, and restoring a healthy microbiome before transplant may lower the risk of GvHD and infections. To be eligible, you must be at least 50 years old, have a hematologic malignancy that requires alloHCT with a reduced-intensity conditioning regimen, have neutrophils above 0.5 G/L, have received broad-spectrum antibiotics in the past 90 days (which damage the microbiome), have a Karnofsky performance score of at least 70, have an available stem cell donor, and provide written consent. Numerous cardiac, pulmonary, hepatic, renal, and gastrointestinal conditions are exclusions, as is pregnancy. Participants will take oral microbiotherapy capsules in the weeks before their transplant. AlloHCT is one of the most intensive treatments in medicine, and GvHD remains its most feared complication. A simple oral supplement that can reprogram the gut microbiome to reduce this risk would be a significant advance for blood cancer patients undergoing one of medicine's most challenging procedures.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPooled allogeneic fecal microbiotherapy

Capsule for oral use

DRUGPlacebo

Capsule for oral use

Locations(54)

Hospital Universitario Virgen del Rocío

Seville, Spain

Hospital Clínico Universitario de Valencia Avenida Blasco Ibáñez

Valencia, Spain

Hospital Universitario La Fe

Valencia, Spain

Cardiff and Vale University Health Board

Cardiff, United Kingdom

Universitair Ziekenhuis Antwerpen

Antwerp, Belgium

AZ Sint - Jan Brugge

Bruges, Belgium

Institut Jules Bordet

Brussels, Belgium

Universitair Ziekenhuis Brussel

Brussels, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Cliniques Universitaires Saint-Luc

Leuven, Belgium

Algemeen Ziekenhuis Delta - Campus Rumbeke

Roeselare, Belgium

CHU Angers

Angers, France

CHU Besançon

Besançon, France

CHU Caen

Caen, France

CHU Grenoble

La Tronche, France

CHRU Lille

Lille, France

Centre Hospitalier Universitaire Limoges

Limoges, France

Institut Paoli Calmettes

Marseille, France

Hôpital Saint-Eloi

Montpellier, France

CHU Nantes Hôtel Dieu

Nantes, France

Hôpital l'Archet

Nice, France

Hôpital Saint-Louis

Paris, France

Hôpital St Antoine

Paris, France

Hôpital Haut-Lévêque

Pessac, France

Centre Hospitalier Lyon-Sud

Pierre-Bénite, France

Centre Hospitalier Universitaire de Poitiers

Poitiers, France

CHU Rennes - Hôpital Pontchaillou

Rennes, France

CHU St Etienne

Saint-Priest-en-Jarez, France

IUCT Toulouse

Toulouse, France

Centre Hospitalier Régional Universitaire de Tours

Tours, France

CHU Tours

Tours, France

Universitätsklinikum Augsburg

Augsburg, Germany

Helios Klinikum Berlin-Buch

Berlin, Germany

Universitätsklinikum Bonn

Bonn, Germany

Universitätsklinikum Essen

Essen, Germany

Universitätsklinikum Frankfurt

Frankfurt, Germany

Universitätsklinikum des Saarlandes

Hombourg, Germany

Universitätsklinikum Schleswig-Holstein - Campus Kiel

Kiel, Germany

Universitätsklinikum Leipzig

Leipzig, Germany

Universitätsmedizin Mannheim

Mannheim, Germany

Klinikum rechts der Isar der Technischen Universität

München, Germany

Universitätsklinikum Ulm

Ulm, Germany

Universitair Medisch Centrum Groningen

Groningen, Netherlands

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitari Vall d'Hebrón

Barcelona, Spain

Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

Barcelona, Spain

Hospital Universitario Virgen de las Nieves

Granada, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, Spain

Hospital General Universitario Morales Meseguer

Murcia, Spain

Clinica Universidad de Navarra - Pamplona

Pamplona, Spain

Complejo Asistencial Universitario de Salamanca - Hospital Clínico

Salamanca, Spain

Hospital Universitario Marques de Valdecilla

Santander, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05762211

Related Trials

Cardiovascular Outcomes and Risk Evaluation Among Recipients of Hematopoietic Stem Cell Transplantation

NCT0734949816 locations

NEgative prEssure Wound Therapy in Renal Transplant

NCT070657341 location

Comparison of Clinical Value in the Use of the Fascia Lata and Temporal Muscle Fascia in the Reconstruction of the Dura in the Sellar Region

NCT064938121 location

The Transplant Cohort of the German Center for Infection Research

NCT063466651 location