Preoperative Nutrition for Crohn's Disease Patients
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|ClinicalTrials.gov Identifier: NCT04398836|
Recruitment Status : Not yet recruiting
First Posted : May 21, 2020
Last Update Posted : May 21, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Malnutrition Crohn Disease||Dietary Supplement: Exclusive Enteral Nutrition Other: High energy / protein diet. Other: Standard nutrition||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Preoperative Nutrition for Crohn's Disease Patients|
|Estimated Study Start Date :||September 2020|
|Estimated Primary Completion Date :||July 2023|
|Estimated Study Completion Date :||December 2027|
Active Comparator: Malnourished patients - EEN
patiens will receive EEN for 4 week prior surgery
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.
Malnourished patients - enriched diet
patiens will receive an enriched high energy and protein diet.
Other: High energy / protein diet.
Mulnourished patients will receive a high energy / protein diet.
Well nourished patients
Patient will receive a standard nutrition
Other: Standard nutrition
Well nurished patients will receive a standard nutrition
- Changes in Compliance to diet [ Time Frame: during every study visit week 0, week 1, week 2, week 3, week 4, 30 days post - surgery ]
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.
- 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.
- Patients will fill-up a 3 day food diary during every study visit to assesses recent dietary composition
- Changes in adherence to therapy [ Time Frame: during every study visit week 1, week 2, week 3, week 4, 30 days post - surgery ]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.
- Changes in tolerability to the diet [ Time Frame: Tolerance will be monitored during every study visit: week 0, week 1, week 2, week 3, week 4 ]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.
- 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. [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04398836
|Contact: Naomi Fliss, PhDfirstname.lastname@example.org|
|Contact: Meytal Kahlon, BAemail@example.com|
|Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center|
|Tel Aviv, Israel|
|Principal Investigator:||Nitsan Maharshak, MD||Tel Aviv Medical Center|