PMID- 36079847 OWN - NLM STAT- MEDLINE DCOM- 20220912 LR - 20220913 IS - 2072-6643 (Electronic) IS - 2072-6643 (Linking) VI - 14 IP - 17 DP - 2022 Aug 31 TI - Malnutrition Prevention after Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT): A Prospective Explorative Interventional Study with an Oral Polymeric Formulation Enriched with Transforming Growth Factor Beta 2 (TGF-beta2). LID - 10.3390/nu14173589 [doi] LID - 3589 AB - Malnutrition is common after allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT), and interventions directed to correct nutritional status are warranted to improve transplant outcomes. In this prospective study, an oral polymeric formulation enriched with TGF-beta2 (TE-OPF) was explored to correct malnutrition according to Patient-Generated Subjective Global Assessment (PG-SGA). TE-OPF was proposed to 51 consecutive patients who received transplants at our institution for hematological malignancies, and sufficient dose intake was established per protocol as at least 50% of the prescribed dose of TE-OPF: group A received adequate nutritional support; group B, inadequate. The study met the primary outcomes in terms of safety (no adverse events reported during TE-OPF intake except for its disgusting taste) and malnutrition (PG-SGA C 28 days after transplant): severely malnourished patients (PG-SGA C) accounted for 13% in group A and 88.9% in group B (p = 0.000). At the end of the study, after a median follow-up of 416 days, the estimated median Overall Survival (OS) was 734 days for well or moderately nourished patients (PG-SGA A/B) in comparison to 424 for malnourished patients (p = 0.03). Inadequate TE-OPF intake was associated with an increase in acute gastrointestinal Graft Versus Host Disease (GVHD) cumulative incidence (38% vs. 0% p = 0.006). A higher incidence of pneumonia was reported in group B (p = 0.006). IGF-1 levels at 14 and 28 days after transplant were significantly higher in group A and were associated with a lower incidence of acute GVHD (aGVHD). Higher subsets of B, T, and NK cells were found in group A, and a higher number of CD16+ NK cells was associated with a lower incidence of acute GVHD (p = 0.005) and increased survival at the end of the study (p = 0.023). Artificial neural network analysis suggested that inadequate TE-OPF intake, pneumonia, and sepsis significantly affected malnutrition 28 days after alloHSCT and survival 365 days after alloHSCT (normalized importance 100%, 82%, and 68%, respectively). In this exploratory and preliminary study, the use of TE-OPF appeared to reduce the incidence of malnutrition after alloHSCT, but larger and controlled studies are required. FAU - Morello, Enrico AU - Morello E AUID- ORCID: 0000-0003-0406-6579 AD - Department of Clinical and Experimental Sciences, University of Brescia, Bone Marrow Transplant Unit, ASST-Spedali Civili di Brescia, 25123 Brescia, Italy. FAU - Arena, Francesco AU - Arena F AD - Department of Clinical and Experimental Sciences, University of Brescia, Bone Marrow Transplant Unit, ASST-Spedali Civili di Brescia, 25123 Brescia, Italy. FAU - Malagola, Michele AU - Malagola M AD - Department of Clinical and Experimental Sciences, University of Brescia, Bone Marrow Transplant Unit, ASST-Spedali Civili di Brescia, 25123 Brescia, Italy. FAU - Farina, Mirko AU - Farina M AUID- ORCID: 0000-0002-2980-9028 AD - Department of Clinical and Experimental Sciences, University of Brescia, Bone Marrow Transplant Unit, ASST-Spedali Civili di Brescia, 25123 Brescia, Italy. FAU - Polverelli, Nicola AU - Polverelli N AUID- ORCID: 0000-0001-6297-9697 AD - Department of Clinical and Experimental Sciences, University of Brescia, Bone Marrow Transplant Unit, ASST-Spedali Civili di Brescia, 25123 Brescia, Italy. FAU - Cavagna, Elsa AU - Cavagna E AD - Department of Clinical and Experimental Sciences, University of Brescia, Bone Marrow Transplant Unit, ASST-Spedali Civili di Brescia, 25123 Brescia, Italy. FAU - Colnaghi, Federica AU - Colnaghi F AD - Department of Clinical and Experimental Sciences, University of Brescia, Bone Marrow Transplant Unit, ASST-Spedali Civili di Brescia, 25123 Brescia, Italy. FAU - Donna, Lorenzo AU - Donna L AD - Department of Clinical and Experimental Sciences, University of Brescia, Bone Marrow Transplant Unit, ASST-Spedali Civili di Brescia, 25123 Brescia, Italy. FAU - Zollner, Tatiana AU - Zollner T AD - Department of Clinical and Experimental Sciences, University of Brescia, Bone Marrow Transplant Unit, ASST-Spedali Civili di Brescia, 25123 Brescia, Italy. FAU - Accorsi Buttini, Eugenia AU - Accorsi Buttini E AD - Department of Clinical and Experimental Sciences, University of Brescia, Bone Marrow Transplant Unit, ASST-Spedali Civili di Brescia, 25123 Brescia, Italy. FAU - Andreoli, Marco AU - Andreoli M AD - Dietetics and Clinical Nutrition Unit, ASST-Spedali Civili Brescia, 25123 Brescia, Italy. FAU - Ricci, Chiara AU - Ricci C AUID- ORCID: 0000-0002-0748-6600 AD - Gastroenterology Unit, ASST-Spedali Civili Brescia-University of Brescia, 25123 Brescia, Italy. FAU - Leoni, Alessandro AU - Leoni A AD - Department of Clinical and Experimental Sciences, University of Brescia, Bone Marrow Transplant Unit, ASST-Spedali Civili di Brescia, 25123 Brescia, Italy. FAU - Samarani, Emanuela AU - Samarani E AD - Department of Clinical and Experimental Sciences, University of Brescia, Bone Marrow Transplant Unit, ASST-Spedali Civili di Brescia, 25123 Brescia, Italy. FAU - Bertulli, Alice AU - Bertulli A AD - Department of Clinical and Experimental Sciences, University of Brescia, Bone Marrow Transplant Unit, ASST-Spedali Civili di Brescia, 25123 Brescia, Italy. FAU - Leali, Daria AU - Leali D AD - Central Laboratory, ASST-Spedali Civili Brescia, 25123 Brescia, Italy. FAU - Bernardi, Simona AU - Bernardi S AUID- ORCID: 0000-0002-3494-2624 AD - Department of Clinical and Experimental Sciences, University of Brescia, Bone Marrow Transplant Unit, ASST-Spedali Civili di Brescia, 25123 Brescia, Italy. FAU - Russo, Domenico AU - Russo D AD - Department of Clinical and Experimental Sciences, University of Brescia, Bone Marrow Transplant Unit, ASST-Spedali Civili di Brescia, 25123 Brescia, Italy. LA - eng PT - Journal Article DEP - 20220831 PL - Switzerland TA - Nutrients JT - Nutrients JID - 101521595 RN - 0 (Transforming Growth Factor beta2) SB - IM MH - *Graft vs Host Disease/etiology/prevention & control MH - *Hematopoietic Stem Cell Transplantation/adverse effects MH - Humans MH - *Malnutrition/etiology MH - Prospective Studies MH - Transforming Growth Factor beta2 PMC - PMC9460256 OTO - NOTNLM OT - GVHD OT - PG-SGA OT - TGF-beta2 OT - allogeneic hematopoietic stem cell transplantation OT - malnutrition COIS- This research was partially funded by Nestle Health Science (Italy) and Associazione Italiana Leucemie (AIL-Sezione di Brescia) with a study grant for a dietitian support for the department. EDAT- 2022/09/10 06:00 MHDA- 2022/09/14 06:00 PMCR- 2022/08/31 CRDT- 2022/09/09 01:25 PHST- 2022/07/27 00:00 [received] PHST- 2022/08/24 00:00 [revised] PHST- 2022/08/25 00:00 [accepted] PHST- 2022/09/09 01:25 [entrez] PHST- 2022/09/10 06:00 [pubmed] PHST- 2022/09/14 06:00 [medline] PHST- 2022/08/31 00:00 [pmc-release] AID - nu14173589 [pii] AID - nutrients-14-03589 [pii] AID - 10.3390/nu14173589 [doi] PST - epublish SO - Nutrients. 2022 Aug 31;14(17):3589. doi: 10.3390/nu14173589.