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NCT Number: NCT07010068

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

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.

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Key information

Conditions

Malnutrition (Calorie) Graft vs Host Disease Immune System Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Stem Cell Transplant Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TGF-β2-enriched food for special medical purposes

Dietary Supplement

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).

BST

Dietary Supplement

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

Primary outcomes

Prevention

Time frame: given from day -7 to day +28

● PG-SGA score C (severe malnutrition) at day +28 <50%

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandro Leoni, MSC

CONTACT

[email protected]

0303998467 ext. +39

Enrico Morello, MD, PhD

CONTACT

[email protected]

0303996811 ext. +39

Sponsors and collaborators

Lead sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Other

Registry information

Official study 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)

Acronym: TGF-Nutri

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: Jun 8, 2025
Registry last updated: Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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