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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TGF-β2-enriched food for special medical purposes, BST.
- Who it may be relevant to
- Registry conditions: Malnutrition (Calorie), Stem Cell Transplant Complications. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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)
Overview
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 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
Primary outcome measures
- Prevention [Time frame: given from day -7 to day +28]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07010068 · NP 6412