Treatment of gastro-intestinal graft vs. host disease with rectal infusion of bacteria in patients not responsive to steroids

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 32

Inclusion Criteria

-Patients who develop a first episode of Stage 3 or 4 GI-aGVHD with gut predominance (Przepiorka D, 1995), resistant to a first line therapy with
steroids (lack of improvement after 5 days or progression after 3 days of treatment with corticosteroids at 2 mg/Kg methylprednisolone
equivalent dose) (SR GI-aGVHD)
-Age = 18 years old
-Allo-HSCT with any type of donor, stem cell source, GVHD prophylaxis or conditioning regimen
-Patients able to have a minimum of 12 hours discontinuation of
systemic antibiotics in order to perform the allogeneic FMT (for patient who received antibiotics MaaT Pharma advises against the use of antibiotics (commonly used) with significant digestive excretion (for example but not limited to: metronidazol, ceftriaxone, levofloxacin))
-Signature of informed and written consent by the subject or by the subject's legally acceptable representative
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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

Exclusion Criteria

Grade IV hyper-acute GVHD as defined by the MD Anderson's criteria (Saliba RM, 2007)
• Late-onset aGVHD as defined by the NIH Consensus Criteria (Jagasia MH, 2015)
• Overlap chronic GVHD as defined by the NIH Consensus Criteria (Jagasia MH, 2015)
• Acute GVHD after donor lymphocytes infusion (DLI)
• Relapsed/persistent malignancy requiring rapid immune suppression withdrawal
• Active uncontrolled infection according to the attending physician
• Current or past veno-occlusive disease or other uncontrolled complication unlesso therwise agreed in writing by the Sponsor.
• Systemic drugs other than corticosteroids for GvHD treatment, including extra-corporeal photopheresis (ECP), unless treatments began before or concomitantly with corticosteroid treatment. New therapies after corticosteroids are a definitive non-inclusion criterium.
• Drugs for GvHD prevention (e.g., calcineurin inhibitors, Mycophenolate mofetil (MMF), ECP…), are allowed as long as treatment began before or
concomitantly with the corticosteroid treatment.
• Absolute neutrophil count < 0.5 x 109 /L
• Absolute platelet count < 10 000
• Patient with negative IgG EBV serology
• Current or past evidence of toxic megacolon, bowel obstruction or gastrointestinal perforation on abdominal X-ray
• Known allergy or intolerance to trehalose or maltodextrin
• Vulnerable patients such as: minors, persons deprived of liberty, persons in Intensive Care Unit unable to provide informed consent prior to the intervention
• Pregnancy: positive urinary or blood test in females of childbearing potential; lactation; absence of effective contraceptive method for
females of childbearing potential throughout the entire duration of the study
• Other ongoing interventional protocol that might interfere with the current study's primary endpoint.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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