Clinical Trial

Nutritional Support With TGF-β2 Food for Special Medical Purposes (TGF-β2 FSMP) in Adult Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT) for the Prevention of Malnutrition: a Prospective, Randomized, Multicenter Study

Study acronym: TGF-Nutri
Not Yet Recruiting
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Summary
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.
Trial Details
NCT Number NCT07010068
Lead Sponsor Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Conditions Malnutrition (Calorie), Stem Cell Transplant Complications
Enrollment 214 participants
Start Date 2025-06-01
Primary Completion 2028-06 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2025-06-08