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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treated patients | Experimental | Treated with Fecal Microbiota Transfer (FMT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fecal microbiota transfer | Drug | transfer of fecal microbiota from healthy donors to the patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | up to 4 weeks post inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | through study completion, an average of six months |
| Gastrointestinal GVHD overall response rate at D28 post inclusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Florent Malard, MD, PhD | Hôpital Saint Antoine - PARIS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens | Amiens | 80054 | France | |||
| CHU Angers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37654670 | Derived | Malard F, Loschi M, Huynh A, Cluzeau T, Guenounou S, Legrand F, Magro L, Orvain C, Charbonnier A, Panz-Klapuch M, Desmier D, Mear JB, Cornillon J, Robin C, Daguindau E, Bilger K, Vehreschild MJGT, Chevallier P, Labussiere-Wallet H, Mediavilla C, Couturier MA, Bulabois CE, Camus V, Chantepie S, Ceballos P, Gaugler B, Holler E, Dore J, Prestat E, Gasc C, Plantamura E, Mohty M. Pooled allogeneic faecal microbiota MaaT013 for steroid-resistant gastrointestinal acute graft-versus-host disease: a single-arm, multicentre phase 2 trial. EClinicalMedicine. 2023 Jul 26;62:102111. doi: 10.1016/j.eclinm.2023.102111. eCollection 2023 Aug. |
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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) |
| Day 28 |
| Number of patients with infectious disorders | Evaluation of FMT activity on infectious disorders | 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 | through study completion, an average of six months |
| Number of patients with Chronic GVHD | Chronic GVHD expression | through study completion, an average of six months |
| Angers |
| 49933 |
| France |
| CHRU Besançon | Besançon | 25030 | France |
| Hôpital Henri Mondor | Créteil | 94000 | France |
| CHRU Lille | Lille | 59037 | France |
| CHU Limoges | Limoges | 87000 | France |
| CHU Nantes | Nantes | 44000 | France |
| Hôpital Saint Antoine | Paris | 75012 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69310 | France |
| Institut de Cancérologie de la Loire | Saint-Priest-en-Jarez | 42270 | France |
| CHU Strasbourg | Strasbourg | 67098 | France |
| IUCT Oncopole | Toulouse | 31100 | France |
| Gemelli Hospital | Roma | 168 | Italy |
| Klinika Hematologii i Transplantologii | Gdansk | 80-952 | Poland |
| Public Clinic Hospital | Katowice | 40-032 | Poland |
| University Clinical hospital | Wroclaw | 50-556 | Poland |
| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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