Patient who underwent Allogeneic hematopoietic stem cell transplantation (allo-HSCT) for various haematological malignancies. Faecal microbiota transplantation (FMT) will be assessed to prevent allogeneic complications such as graft-versus-host disease (GvHD) and infection which remain a major cause of morbidity, mortality, and impaired quality of life. During the conditioning regimen and after the allo-HSCT, many treatments can negatively impact microbiota homeostasis.
Conditions
Interventions
Product Name: Fecal Microbiota Transplantation
Pharmaceutical Form: Concentrate for rectal solution
Sponsors
CHU de Clermont-Ferrand
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients who underwent allo-HSCT for a controlled haematological malignancy. • Patients aged = 18 years old. • Patients affiliated with a social security organization. • Patients who had signed informed consent. • Allo-HSCT procedure: MAC followed by a granulocyte-colony stimulating factor mobilized-peripheral HSC graft infusion. • Any HSCT donor, except cord blood. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 125 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: • Medical history of another progressive uncontrolled cancer within the previous three years. • Presence of a simultaneous serious and uncontrolled disease. • Faecal incontinence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of allogeneic FMT compared with no treatment on graft-versus-host disease-free, relapse-free survival (GRFS) at one year post-transplant in patients treated with myeloablative conditioning (MAC) allo-HSCT for haematological malignancy.;Secondary Objective: •To evaluate incidence of engraftment, incidence of aGvHD and cGvHD, overall survival, progression-free survival, transplant-related mortality, quality of life, rate of severe infections. •To evaluate the tolerance and safety of post-allo-HSCT FMT, its effect on multidrug-resistant bacteria/extended spectrum beta-lactamases (ESBL), the cumulative incidence of clostridium difficile infection and diarrhoea. •To evaluate microbiota composition and diversity by 16s sequencing prospectively in all patients (treatment group and control group) before allo-HSCT, before FMT and at M1, M3 and M12, and in donors. ;Primary end point(s): Graft-versus-host disease-free, relapse-free survival (GRFS) ;Timepoint(s) of evaluation of this end point: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Incidence of engraftment - Incidence of aGvHD - Incidence of cGvHD - Overall survival - Progression-free survival - Transplant-related mortality - Quality of life - Rate of severe infections - Tolerance and safety of post-allo-HSCT FMT - Effect on multidrug-resistant bacteria/extended spectrum beta-lactamases (ESBL) - Cumulative incidence of clostridium difficile infection and diarrhoea - Microbiota composition and diversity by 16s sequencing prospectively in all patients (treatment group and control group) and in donors. ;Timepoint(s) of evaluation of this end point: - Rate of engraftment at day 100 - Cumulative incidence of grade II-IV acute GvHD at 1 year - Cumulative incidence of chronic GvHD at 2 years - Overall survival and progression-free survival at 1 and 2 years - Transplant related mortality at six months, 1 and 2 years. - Quality of life at inclusion, M1, M3, M6, M12 and M24. - Cumulative incidence of infectious disease at 1 year - Tolerance and safety after allo-HSCT - Effect on multidrug-resistant bacteria and ESBL at 1 year - Cumulative incidence of clostridium difficile infection at 1 year - Cumulative incidence of diarrhoea at 6 months - Microbiota composition and diversity assessed by 16s sequencing performed prospectively in all patients (before allo-HSCT, before FMT, and at M1, M3 and M12 post FMT) and in donors | — |
Countries
France
Contacts
Public ContactDirection de la Recherche Clinique
CHU de Clermont-Ferrand
Outcome results
None listed