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: 24

Inclusion Criteria

1. Patients who develop a first episode of Grade III or IV aGVHD (= gastrointestinal Stages 2 to 4) with gut predominance if other organs involved (Przepiorka D, 1995), resistant to a first-line therapy with steroids, defined as any of the following:
a. Lack of improvement after 5 to 7 days of treatment with CS at 2mg/kg/d methylprednisolone equivalent dose.
b. Progression after 3 days of treatment with CS at 2 mg/kg/d methylprednisolone equivalent dose.
c. Patients treated with 1 mg/kg/d of CS because the physician deemed they would not tolerate 2 mg/kg/d and who correspond to the definition of SR patients.
2.Age = 18 years old
3.Allo-HSCT with any type of donor, stem cell source, GVHD prophylaxis or conditioning regimen
4.Patients able to have a minimum of 12 hours discontinuation of systemic antibiotics in order to perform the allogeneic FMT (for patients who require antibiotics, using antibiotics that have limited impact on the gut microbiota should be considered in priority. The complete list of recommended and not recommended antibiotics is in Appendix 6)
5.Signature of informed and written consent by the subject or by the subject’s legally acceptable representative for patients under guardianship or trusteeship

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

1.Grade IV hyper-acute GVHD as defined by the MD Anderson’s criteria (Saliba RM, 2007)
2.Overlap chronic GVHD as defined by the NIH Consensus Criteria (Jagasia MH, 2015)
3.Acute GVHD after donor lymphocytes infusion (DLI)
4.Relapsed/persistent malignancy requiring rapid immune suppression withdrawal
5.Active uncontrolled infection according to the attending physician
6.Current or past veno-occlusive disease or other uncontrolled complication unless otherwise agreed in writing by the sponsor.
7.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.
8.Absolute neutrophil count < 0.5 x 109 /L
9.Absolute platelet count < 10 000
10.Patient with negative IgG EBV serology
11.Current or past evidence of toxic megacolon, bowel obstruction or gastrointestinal perforation on abdominal X-ray
12.Known allergy or intolerance to trehalose or maltodextrin
13.Vulnerable patients such as: minors, persons deprived of liberty, persons in Intensive Care Unit unable to provide informed consent prior to the intervention
14.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
15.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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