Patients who have a gastrointestinal acute Graft versus host disease (GVHD) received a first-line standard treatment of corticosteroids. For patients who do not respond or progress after an initial response have a high mortality. There is an interest in identifying effective second line therapy for these patients corticosteroid-resistant acute GVHD. Fecal microbiota transfer might be a beneficial treatment in this clinical situation with a poor prognosis and limited therapeutic options.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
transfer of fecal microbiota from healthy donors to the patients
CHU Amiens
Amiens, France
CHU Angers
Angers, France
CHRU Besançon
Besançon, France
Efficacy of FMT in the treatment of Steroid Refractory -Gastro-intestinal Acute GVHD (SR-GI-aGVHD) at D28 post inclusion
Proportion of patients achieving GI and overall GVHD response by D28, defined as Complete response (CR) or Very Good Partial Response (VGPR)
Time frame: up to 4 weeks post inclusion
Safety of FMT in patients with SR-GI-aGVHD
The overall safety of the study will be evaluated with the incidence of all Adverse Events (AEs) and Serious Adverse Events (SAEs) (frequency, grade, relationship) throughout the study period
Time frame: through study completion, an average of six months
Gastrointestinal GVHD overall response rate at D28 post inclusion
Proportion of patients achieving GI and overall GVHD response by D28, defined as Complete response (CR) or Very Good Partial Response (VGPR) or Partial Response (PR)
Time frame: Day 28
Number of patients with infectious disorders
Evaluation of FMT activity on infectious disorders
Time frame: through study completion, an average of six months
Number of multidrug resistant bacteria in faeces
Evaluation of FMT activity on multidrug-resistant bacteria (MDRB) carriage
Time frame: through study completion, an average of six months
Number of patients with Chronic GVHD
Chronic GVHD expression
Time frame: through study completion, an average of six months
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Hôpital Henri Mondor
Créteil, France
CHRU Lille
Lille, France
CHU Limoges
Limoges, France
CHU Nantes
Nantes, France
Hôpital Saint Antoine
Paris, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, France
...and 6 more locations