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Preoperative Nutrition for Crohn's Disease Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04398836
Recruitment Status : Not yet recruiting
First Posted : May 21, 2020
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
michal roll, Tel-Aviv Sourasky Medical Center

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.


Condition or disease Intervention/treatment Phase
Malnutrition Crohn Disease Dietary Supplement: Exclusive Enteral Nutrition Other: High energy / protein diet. Other: Standard nutrition Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

    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

  2. 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.

  3. 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.


Secondary Outcome Measures :
  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. [ 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

• CD patients awaiting surgery

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Naomi Fliss, PhD 97236974924 naomifl@tlvmc.gov.il
Contact: Meytal Kahlon, BA 97236972428 meytalkah@tlvmc.gov.il

Locations
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Israel
Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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Principal Investigator: Nitsan Maharshak, MD Tel Aviv Medical Center
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Responsible Party: michal roll, Director, R&D Department, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT04398836    
Other Study ID Numbers: 0825-18TLV
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Malnutrition
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Nutrition Disorders