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

NCT ID: NCT07010068

Last Updated: 2025-06-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2028-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

MODULEN-IBD SUPPLEMENTATION

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,

Group Type: EXPERIMENTAL

TGF-β2-enriched food for special medical purposes

Intervention Type: 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 (Best Supportive Treatment)

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.

Group Type: ACTIVE_COMPARATOR

BST

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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).

Intervention Type: DIETARY_SUPPLEMENT

BST

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

OTHER

Sponsor Role: lead

Responsible Party

Enrico Morello

Enrico Morello, Principal Investigator, Head of Supportive Care Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Enrico Morello, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asst Degli Spedali Civili Di Brescia

Central Contacts

Enrico Morello, MD, PhD

Role: CONTACT

enrico.morello@asst-spedalicivili.it

0303996811 ext. +39

Alessandro Leoni, MSC

Role: CONTACT

alessandro.leoni@unibs.it

0303998467 ext. +39

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NP 6412

Identifier Type: -

Identifier Source: org_study_id