Trials / Not Yet Recruiting

Not Yet RecruitingNCT07010068

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

Status: Not Yet Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 214 (estimated)

Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Conditions

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	TGF-β2-enriched food for special medical purposes	The 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).
DIETARY_SUPPLEMENT	BST	Best Nutritional Supportive Treatment as per center's policy according to EBMT Handbook 2024

Timeline

Start date: 2025-06-01
Primary completion: 2028-06-01
Completion: 2028-06-01
First posted: 2025-06-08
Last updated: 2025-06-08

Source: ClinicalTrials.gov record NCT07010068. Inclusion in this directory is not an endorsement.