prospective, randomized, multicenter study to confirm the potential benefits of TGF-β2 enriched FSMP. The primary objective is to evaluate the superiority of supplementing with TGF-β2 FSMP (experimental arm) compared to best supportive treatment (BST) in preventing malnutrition in patients submitted to allo-SCT. The secondary endpoints include the assessment of reduction of incidence of severe acute GVHD at day +100.
Intact intestinal tract
Life expectancy more than 12 weeks
Allogeneic stem cell transplantation
Signed informed consent
Active hematological disease at the beginning of conditioning
Personal history of inflammatory bowel diseases
Personal history of bowel resection
Personal history of gastric bypass procedures
Parallel
TGF-β2-enriched food for special medical purposes
Dietary supplementThe experimental treatment is Modulen-IBD®, a food for special medical purpose, polymeric, enriched with TGF-beta. If the patient refuses the experimental supplementation, NGT will be proposed to ensure the correct intake of Modulen-IBD® supplementation. If the patient refuses, not tolerates, or there are contraindications to NGT placement, best supportive therapy will be warranted as reported below (BST).
BST
Dietary supplementBest Nutritional Supportive Treatment as per center's policy according to EBMT Handbook 2024
Prevention
● PG-SGA score C (severe malnutrition) at day +28 \<50%
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