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-Nutri)

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Status: Not yet enrolling

Conditions: Stem Cell Transplant Complications; Malnutrition (Calorie)

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07010068

NP 6412

Details and patient eligibility

About

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.

Enrollment: 214 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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214 participants in 2 patient groups

MODULEN-IBD SUPPLEMENTATION

Experimental group

Description:

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,

Treatment:

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

BST (Best Supportive Treatment)

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: BST