Nutritional Support With Oral Polymeric Formulation Enriched With Transforming Growth Factor beta 2 (TGF-β2) in Allogenic Hematopoietic Stem Cells Transplantation (Allo-hsct): A Prospective Interventional Study

Abstract: PurposeIn the allogeneic transplant setting (allo-HSCT), the prevalence of malnutrition at admission is usually low, but at discharge, may be 60% or more and it may affect the transplant outcome.The aim of this study was to reduce the incidence of severe malnutrition (PG-SGA C) at day + 28 days from allo-HSCT in patients supported with an oral polymeric formulation enriched with Transforming Growth Factor beta 2 (TGF-β2).MethodsFifty-one patients were consecutively enrolled between March 2020 and June 2021 in this prospective interventional study. As a group of control, we have retrospectively analyzed an observational cohort composed by thirty patients submitted to allo-HSCT from august 2017 and august 2018 in our institution.ResultsThe incidence of severe malnourished patients (PG-SGA C) at + 28 days was significantly lower in the group with an oral nutritional support (ONS) treatment ratio (TR) major than 50% (TR>50%) in comparison to the ones with less than 50% ONS assumption (TR<50%) (13% vs 88.9% P=0.000). Interestingly, cumulative incidence of gastrointestinal (GI) aGVHD was significantly lower in patients assuming 50% or more of the prescribed ONS dose in comparison to those who assumed less than 50% of ONS (0%, vs 29.6%; p=0.005). Pneumonia was more frequent in patients with TR < 50% compared to patients with TR > 50% (48.1 % and 12.5 % respectively)(p=0.006).ConclusionMODULEN-IBD® seems to be a promising ONS to reduce malnutrition in allogeneic stem cell transplantation and should be tested in a randomized controlled prospective trial. MODULEN-IBD® may also have some positive immunological effects on gastrointestinal GVHD and infections that should be explored in larger studies.