Preoperative Nutrition for Crohn's Disease Patients

NCT04398836 | Not Yet Recruiting Phase 3

• 1 other identifier: 0825-18TLV
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malnutrition; Crohn Disease

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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.

  Tolerance will be monitored during every study visit: week 0, week 1, week 2, week 3, week 4

Secondary Outcomes (1)

• 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.

  One month after surgery

Study Arms (3)

Malnourished patients - EEN

ACTIVE COMPARATOR

patiens will receive EEN for 4 week prior surgery

Dietary Supplement: Exclusive Enteral Nutrition

Malnourished patients - enriched diet

OTHER

patiens will receive an enriched high energy and protein diet.

Other: High energy / protein diet.

Well nourished patients

OTHER

Patient will receive a standard nutrition

Other: Standard nutrition

Interventions

Exclusive Enteral Nutrition DIETARY_SUPPLEMENT

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 - EEN

High energy / protein diet. OTHER

Mulnourished patients will receive a high energy / protein diet.

Malnourished patients - enriched diet

Standard nutrition OTHER

Well nurished patients will receive a standard nutrition

Well nourished patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CD patients awaiting surgery

You may not qualify if:

• Pregnancy and lactation
• Subjects on TPN
• Subjects with chronic conditions such as cancer, organ transplant subjects, advanced kidney or liver disease, systemic inflammatory conditions other than IBD
• Inability to sign informed consent and complete study protocol
• Surgical procedure to reverse ileostomy/colostomy or abscess drainage

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Malnutrition; Crohn Disease

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Nitsan Maharshak, MD

  Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naomi Fliss, PhD

CONTACT

97236974924; naomifl@tlvmc.gov.il

Meytal Kahlon, BA

CONTACT

97236972428; meytalkah@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, R&D Department

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: May 21, 2020
• Study Start: September 1, 2020
• Primary Completion: July 1, 2023
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 21, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)