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

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 - (TGF-NUTRIALLO Study)

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07010068

Acronym

TGF-Nutri

Enrollment

214

Registered

2025-06-08

Start date

2025-06-01

Completion date

2028-06-30

Last updated

2025-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition (Calorie), Stem Cell Transplant Complications

Keywords

Stem Cell Transplant, malnutrution, gvhd

Brief 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.

Interventions

DIETARY_SUPPLEMENTTGF-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_SUPPLEMENTBST

Best Nutritional Supportive Treatment as per center's policy according to EBMT Handbook 2024

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Intervention model description

Prospective, open-label, randomized, multicentric, interventional TGF-β2-enriched supplementation (Modulen IBD ®) in patients submitted to allogeneic hematopoietic stem cell transplantation (allo-HSCT)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Intact intestinal tract * Life expectancy more than 12 weeks * Allogeneic stem cell transplantation * Signed informed consent

Exclusion criteria

* 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 * Enrolment in a competitive prospective study (malnutrition or GVHD as primary outcome) * Subjects with known hypersensitivity to milk proteins or components of Modulen-IBD

Design outcomes

Primary

Measure	Time frame	Description
Prevention	given from day -7 to day +28	● PG-SGA score C (severe malnutrition) at day +28 \<50%

Contacts

Primary ContactEnrico Morello, MD, PhD

enrico.morello@asst-spedalicivili.it0303996811

Backup ContactAlessandro Leoni, MSC

alessandro.leoni@unibs.it0303998467

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026