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

ConditionsMalnutrition (Calorie)Stem Cell Transplant Complications

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

About this trial

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.

Eligibility criteria

Qualifiers

Intact intestinal tract

Life expectancy more than 12 weeks

Allogeneic stem cell transplantation

Signed informed consent

Disqualifiers

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

Trial design

Treatments tested in this trial

TGF-β2-enriched food for special medical purposes
BST

Treatment groups

214 Participants

are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Lead sponsor

Source ClinicalTrials.gov