A Phase 3 interventional study of Exclusive Enteral Nutrition and High energy / protein diet. in Malnutrition and Crohn Disease, sponsored by Tel-Aviv Sourasky Medical Center. Not yet recruiting at 1 site in Israel. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-05-21.
Sponsored by Tel-Aviv Sourasky Medical Center · Phase 3, Interventional, and Treatment
The investigator hypothesizes that compliance to Exclusive enteral nutrition (EEN) will be high among patients on an operation for their bowel disease, compared to the compliance rate seen in the general Crohn's Disease (CD) population.
Also,the investigator hypothesizes that clinical outcomes would improve, and post-operative complication rate will be reduces in malnourished CD patients receiving pre-operative 4 weeks EEN during the 4 weeks post-surgery, compared to CD patients receiving high energy and protein diet without EEN.
Study design:
A randomized, none-blinded study. Study population: 144 CD patients designated for surgery, 96 malnourished patients and 44 well-nourished patients. Participants will be recruited from the Department of Gastroenterology, from Surgery Department and from the Nutrition Unit in the Tel Aviv Medical Center (TLVMC).
Study procedure CD patients who are awaiting surgery will be screened and randomly assigned to the study. After the decision to perform surgery and patient's acceptance to participate in the study but not more than 3 months before scheduled surgery, patient will undergo nutritional assessment. Patients suffering from malnutrition will be randomly assigned to the EEN group or to the group receiving enriched high energy and protein diet. Well-nourished patients will continue with standard nutritional therapy. Malnutrition will be defined according to Subjective Global Assessment (SGA)
Screening procedure:
Patients assigned to the interventional arm would be asked to adhere to EEN for two days prior to inclusion in order to assess tolerability and adherence to the assigned diet. Those who are not able to adhere to a two day EEN diet , will be withdrawn from the interventional arm, and will be treated with a high energy, high protein diet as the control group in accordance to the study protocol.
Study group:
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 period patients 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 CD. VITAL includes all the nutritional macro and micronutrients and can serve as a sole source of nutrition. In cases of severe nutritional deterioration throughout the study, supplemental parenteral nutrition will be considered.
Control group:
Nutritional support by high energy/high protein diet, calculated by 25-30 kcal/kg and at least 1 gr/kg of protein. In cases of significant nutritional deterioration throughout the study, oral nutritional supplements or supplemental parenteral nutrition will be considered.
Well-nourished patient group: accepted standard nutritional therapy.
Compliance and dietary evaluation:
Patients will fill-up a 3 day food diary during every study visit to assesses recent dietary composition. Adherence to therapy will also monitored using the Medication Adherence Rating Scale (MARS) questionnaire.
Nutrients intake will be computed with the Israeli nutritional software "Zameret". Patients in the EEN group will be required to return the empty enteral formula containers.
Compliance to the diet instructed for the patient will be concidured as intake of 80% of calories per patient.
Compliance to the diet instructed for the patient will be concidured as intake of 80% of calories per patient.
Tolerability to EEN:
Tolerance will be defined as ingestion of the entire amount of formula requested by the patient without the development of any allergic/intolerant symptoms. Tolerance will be monitored during every study visit.
Disease activity:
Disease activity will be evaluated by serum C- Reactive Protein (CRP) concentration, fecal calprotectin concentration and Harvey-Bradshaw index (HBI).
Metabolic evaluation
Anthropometric measurements:
Biochemical tests:
All blood samples will be drawn at the morning following 12 hours fast: albumin, blood count, serum CRP concentration and fecal calprotectin concentration.
Post operative clinical course:
Patient post-operative course will be documented from patients medical file. Parameters will include: hospitalization length, blood transfusions and other interventions, post operative medical treatment.
Fecal samples:
Stool will be analyzed for fecal calprotectin and for characterizing the microbial composition
Assessment of surgical complications
The following complications will be monitored 30d after surgery:
Safety EEN is an accepted and recommended therapy for CD patients and considered a first-line therapy for inducing remission in children.
1,880 studies on the registry are indexed under Crohn Disease; 461 are open to participants now.
This study's planned enrollment of 144 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Tel-Aviv Sourasky Medical Center is the lead sponsor of 541 studies on the registry; 49 are open to participants now.
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Exclusion Criteria:
patiens will receive EEN for 4 week prior surgery
Dietary Supplement: Exclusive Enteral Nutrition
patiens will receive an enriched high energy and protein diet.
Other: High energy / protein diet.
Patient will receive a standard nutrition
Other: Standard 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.
Mulnourished patients will receive a high energy / protein diet.
Well nurished patients will receive a standard nutrition
Changes in Compliance to diet
During every study visit compliance to diet instructed, monitor every week since initiating: week 0, week 4, 30 days post - surgery by 3 days food diary calculated average consumption of kcal and protein in grames. The same assessment carried out at week 1, week 2, week 3, by 24 - hour recall questionnaire. High Compliance considered if Calories \> 80% protein ≥ 1 gr/kg from the expected metabolic assessment needs for each week 1-4 dietary intervention, and present better outcomes. 1. using the MARS questionnaire - Medication Adherence Rating Scale. The patient should be asked to respond to the statements in the questionnaire by circling the answer which best describes their behaviour or attitude towards their medication during the past week. 2. Patients will fill-up a 3 day food diary during every study visit to assesses recent dietary composition
Time frame: during every study visit week 0, week 1, week 2, week 3, week 4, 30 days post - surgery
Changes in adherence to therapy
During every study visit week 1, week 2, week 3, week 4, 30 days post - surgery, MARS, Medication Adherence Rating Scale - questionnaire filled by subject: Patient asked to respond to the statements in the questionnaire by circling the answer best describes their behavior or attitude towards their diet prescription during the past week. Score range between: min of 10-19 - no adherence to diet, 40-49 often adherence, 50 max score present permanent adherence.
Time frame: during every study visit week 1, week 2, week 3, week 4, 30 days post - surgery
Changes in tolerability to the diet
Tolerance will be monitored during every study visit week 0, week 1, week 2, week 3, week 4, as ingestion of the entire amount of formula requested by the patient without the development of any allergic/intolerant symptoms, report on changes in tolerance documented and monitored in tailored form.
Time frame: Tolerance will be monitored during every study visit: week 0, week 1, week 2, week 3, week 4
The rate of post-operative complications in malnourished CD patients receiving pre-operative 4 weeks EEN, is changed during the 4 weeks post-surgery, compared to CD patients receiving high energy and protein diet without EEN one month after surgery.
Patient post-operative course documented from patients' medical file. Parameters include: hospitalization length, blood transfusions and other interventions, post - operative medical treatment and complications.
Time frame: One month after surgery
Plan to share: No
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Tel-Aviv Sourasky Medical Center