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,

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.

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).

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