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

NCT07010068 | Not Yet Recruiting

• 1 other identifier: NP 6412
• Study Type: interventional
• Target: 214
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Malnutrition (Calorie); Stem Cell Transplant Complications

Keywords

Stem Cell Transplant; malnutrution; gvhd

Outcome Measures

Primary Outcomes (1)

• Prevention

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

  given from day -7 to day +28

Study Arms (2)

MODULEN-IBD SUPPLEMENTATION

EXPERIMENTAL

From hospital admission to day +28 calories by Modulen-IBD® will integrate oral diet with 20% of calories by Modulen IBD® of TDEE, according to table 2 and to twice weekly monitoring Oral administration: Once reconstituted with bottled water according label instructions and at a caloric concentration of ≤1 kcal/ml, the supplement could be flavored according to the patient's tastes with barley coffee or decaffeinated coffee or cocoa. It is recommended to take in 2-3 portions to be taken throughout the day. NGT route: Placement of a small NGT (max 8-10 fr.) is recommended. Food assumption is encouraged even when NGT is placed. In case of NGT placement, the amount of calories by tube is the difference between TDEE and the amount of calories assumed with food. Modulen IBD® will be prepared and administered in 100-250 ml boluses (every 4-6 hours) to ensure the stability of the product. If a patient refuses food, Enteral Nutrition as polymeric standard, isocaloric, isoproteic, +/- fibers,

Dietary Supplement: TGF-β2-enriched food for special medical purposes

BST (Best Supportive Treatment)

ACTIVE COMPARATOR

Nutritional support in patients randomized to BST should be carried out according to EBMT-Handbook standards. If the patient's caloric intake is less than 75% for 3 days (instead 60% as proposed by EBMT manual) nutritional intervention is warranted and calculated according to BMI (see above). ONS: ONS should ensure the same amount of caloric intake of the experimental treatment in addition to usual food assumption. If patients could not assume the right amount of calories with ONS and refuse NGT parenteral nutrition is permitted. Parenteral Nutrition (PN): 3-1 formulations with a 1.1 Kal/ml content should be preferred (ex. Smofkabiven®, Olimel®) through a central line. The choice of PN type is according to the center's policy and used in combination with food or ONS assumption.

Dietary Supplement: BST

Interventions

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).

MODULEN-IBD SUPPLEMENTATION

BST DIETARY_SUPPLEMENT

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

BST (Best Supportive Treatment)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead

MeSH Terms

Conditions

Malnutrition; Graft vs Host Disease

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Immune System Diseases

Study Officials

• Enrico Morello, MD, PhD

  Asst Degli Spedali Civili Di Brescia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enrico Morello, MD, PhD

CONTACT

0303996811; enrico.morello@asst-spedalicivili.it

Alessandro Leoni, MSC

CONTACT

0303998467; alessandro.leoni@unibs.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Enrico Morello, Principal Investigator, Head of Supportive Care Unit

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

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 8, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share