Preoperative Nutrition for Crohn's Disease Patients

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

September 30, 2020

Primary Completion Date

July 31, 2023

Study Completion Date

December 31, 2027

Conditions
MalnutritionCrohn Disease
Interventions
DIETARY_SUPPLEMENT

Exclusive Enteral Nutrition

Mulnourished patients will drink an enteral polymeric formula suited to their energy expenditure calculated by 25-30 kcal/kg and at least 1 gr/kg of protein, a minimum of 1500 ml (1500 kcal, 54 gr of protein). The amount of formula to achieve nutritional requirements are based on body weight, but the average intake is of 6-8 cups of formula (36-48 scoops of formula mixed with 1260-1680 ml of water to achieve a concentration of 1 kcal per ml). During this period patients will be guided to avoid eating and drinking anything but the enteral formula. The formula will be supplied to the patients by the investigators. The formula used for this study will be VITAL - suitable for people with disease-related malnutrition and malabsorption. Vital 1.5kcal is peptide-based, nutritionally complete formulation for the dietary management of active phase of Crohn's disease. VITAL includes all the nutritional macro and micronutrients and can serve as a sole source of nutrition.

OTHER

High energy / protein diet.

Mulnourished patients will receive a high energy / protein diet.

OTHER

Standard nutrition

Well nurished patients will receive a standard nutrition

Trial Locations (1)

Unknown

Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center, Tel Aviv

All Listed Sponsors
lead

Tel-Aviv Sourasky Medical Center

OTHER_GOV