NCT04935684 Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation
| NCT ID | NCT04935684 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Hospital, Clermont-Ferrand |
| Condition | Acute Leukemia in Remission |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2022-12-20 |
| Primary Completion | 2030-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 150 participants in total. It began in 2022-12-20 with a primary completion date of 2030-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this study is to assess the Fecal Microbiota Transplantation (FMT) efficacy in the prevention of allogeneic hematopoietic stem cell transplantation (allo-HSCT) complications and particularly Graft versus Host Disease (GvHD). The hypothesis of this study is that allogeneic FMT may improve outcomes of these patients.
Eligibility Criteria
Inclusion Criteria: * Patient aged 18 or over * Men and women * Patients affiliated with a social-security organization * Patients undergoing a myelo-ablative allo-HSCT for a controlled haematologic malignant disease, with peripheral stem cells, whatever the type of donor (except cord blood) * Signed and dated informed consent Exclusion Criteria: * Status of tumor progression at the time of allo-HSCT * Inability to understand the protocol (linguistic barrier, cognitive difficulties) * Medical history of another progressive cancer or occurrence in the 3 previous years (excluding basal cell carcinoma) * Presence of a simultaneous serious and uncontrolled disease (severe cardiac, renal, hepatic or respiratory failure, severe sepsis) * Fecal incontinence * Participation in another clinical trial studying an allograft procedure including the type of graft, the type of immunosuppression, a preventive or a curative treatment of GvHD, or studying the effectiveness of a FMT in another indication. * Pregnant women * Patient under guardianship, curatorship or protection of justice
Contact & Investigator
Jacques-Olivier BAY, MD, PhD
PRINCIPAL INVESTIGATOR
University Hospital, Clermont-Ferrand
Frequently Asked Questions
Who can join the NCT04935684 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Leukemia in Remission. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04935684 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04935684 currently recruiting?
Yes, NCT04935684 is actively recruiting participants. Contact the research team at promo_interne_drci@chu-clermontferrand.fr for enrollment information.
Where is the NCT04935684 trial being conducted?
This trial is being conducted at Amiens, France, Angers, France, Besançon, France, Clermont-Ferrand, France and 11 additional locations.
Who is sponsoring the NCT04935684 clinical trial?
NCT04935684 is sponsored by University Hospital, Clermont-Ferrand. The principal investigator is Jacques-Olivier BAY, MD, PhD at University Hospital, Clermont-Ferrand. The trial plans to enroll 150 participants.
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