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Diet for Induction and Maintenance of Remission and Re-biosis in Crohn's Disease (DIETOMICS-CD)

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ClinicalTrials.gov Identifier: NCT02843100
Recruitment Status : Recruiting
First Posted : July 25, 2016
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Arie Levine, Wolfson Medical Center

Tracking Information
First Submitted Date  ICMJE June 22, 2016
First Posted Date  ICMJE July 25, 2016
Last Update Posted Date July 5, 2019
Actual Study Start Date  ICMJE April 10, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
ITT, steroid free Clinical remission (defined as Pediatric Crohn's Disease Activity Index (PCDAI)<10) at week 14 [ Time Frame: week 14 ]
Sustained remission with EEN Vs CDED+PEN
Original Primary Outcome Measures  ICMJE
 (submitted: July 20, 2016)
Clinical remission (defined as Pediatric Crohn's Disease Activity Index (PCDAI)<10) at week 8 [ Time Frame: week 8 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
  • ITT steroid free remission at week 8 [ Time Frame: week 8 ]
    Induction of remission
  • Microbiome composition difference between groups at week 14 [ Time Frame: week 14 ]
    Assessment of microbiome composition and metabolomics
  • 3. Reduction of at least 50% from baseline in fecal calprotectin at week 24 for patients on original treatment [ Time Frame: week 24 ]
    Mucosal healing assessment
  • Steroid and biologic free sustained remission at week 24. [ Time Frame: week 14 and 24 ]
    Remission achieved and maintained without additional therapy
  • Need for additional treatment to achieve remission by week 14 [ Time Frame: Week 14 ]
    Remission achieved without additional therapy
  • Mucosal healing as assessed by MRE in dietary responsive disease at week 52 [ Time Frame: Week 52 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2016)
  • Clinical remission (defined as PCDAI<10) at week 14 [ Time Frame: week 14 ]
  • Response (defined as a drop of 12.5 points in PCDAI) at week 8 [ Time Frame: week 8 ]
  • Steroid free remission (defined as PCDAI<10) at weeks 8 and 24 [ Time Frame: week 24 ]
    Remission achieved and maintained without additional therapy
  • BiologicTherapy free remission (defined as PCDAI<10) at weeks 8 and 24 [ Time Frame: week 24 ]
    Remission achieved and maintained without additional therapy
  • Change in C-Reactive Protein (CRP) at weeks 8, 14 and 24 [ Time Frame: week 24 ]
  • Change in Erythrocyte Sedimentation Rate (ESR) at weeks 8, 14 and 24 [ Time Frame: week 24 ]
  • Change in mean fecal Calprotectin at weeks 8, 14 and 24 [ Time Frame: week 24 ]
  • Change in Microbiome composition at weeks 2,8, 14 and 24 [ Time Frame: week 24 ]
  • Change in Microbiome function (metabolic pathways) at weeks 2,8, 14 and 24 [ Time Frame: week 24 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diet for Induction and Maintenance of Remission and Re-biosis in Crohn's Disease
Official Title  ICMJE Modified Exclusive Enteral Nutrition With the Crohn's Disease Exclusion Diet for Induction and Maintenance of Remission and Re-biosis
Brief Summary The modified-Exclusive Enteral Nutrition (mEEN) is an open label randomized controlled trial in mild to severe Crohn's Disease patients. The purpose of this study is to determine whether induction of remission and maintenance of remission can be achieved with a new dietary strategy that involves only 2 weeks of Exclusive Enteral Nutrition (EEN) with Modulen and 12 weeks of an exclusion diet involving selected table foods. This novel approach will be compared to the gold standard dietary regime involving 8 weeks of EEN.
Detailed Description

Rational: Exclusive enteral nutrition (EEN) is an established but difficult to perform method for induction of remission and cannot be used for maintenance of remission. It entails drinking only liquid formula for 8 weeks. Refusal to use or to adhere to this therapy is not uncommon and leads to use of other non- dietary strategies in children including steroids and immunosuppression. The Crohn's Disease Exclusion Diet (CDED) with partial enteral nutrition has been shown to be effective for children with mild to moderate disease. The investigators have developed a maintenance strategy using the CDED.

Objectives: To prove that induction of remission and maintenance of remission can be achieved with a new dietary strategy that involves only 2 weeks of EEN with Modulen and 12 weeks of an exclusion diet involving selected table foods.

Methods: Open label randomized controlled pilot trial comparing two weeks of EEN followed by the CDED and Partial Enteral Nutrition (PEN), to 8 weeks of EEN followed by PEN with free diet. The study will include a control group of healthy children for microbiome studies.

Population: Age 8-18 years with mild to severe active Crohn's disease defined as 15≤Pediatric Crohn's Disease Activity Index (PCDAI)<47.5.

Time frame: The induction of remission phase will last 8 weeks followed by maintenance phase for a period of 24 weeks.

Expected outcomes and significance: If this method proves to be equivalent to EEN, the duration of use of EEN will be only two weeks, allowing more patients access to dietary therapy. More importantly, this study will also evaluate two maintenance strategies and will be the first to evaluate re-biosis.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • Other: Modified Exclusive Enteral Nutrition
    Two weeks of Exclusive Enteral Nutrition with Modulen
    Other Name: Modulen, Nestle
  • Other: Crohn's Disease Exclusion Diet
    a limited whole food diet
    Other Name: CDED
  • Other: Partial Enteral Nutrition
    25-50% of Energy from formula
    Other Name: Modulen, Nestle
  • Other: Standard Exclusive Enteral Nutrition
    8 weeks of Exclusive Enteral Nutrition
    Other Name: Modulen, Nestle
Study Arms  ICMJE
  • Experimental: Group 1
    Modified Exclusive Enteral Nutrition including two weeks of Exclusive Enteral Nutrition (EEN) using Modulen followed by Partial Enteral Nutrition (PEN) along with the Crohn's Disease Exclusion Diet (CDED) phases 2 & 3 for 24 weeks
    Interventions:
    • Other: Modified Exclusive Enteral Nutrition
    • Other: Crohn's Disease Exclusion Diet
    • Other: Partial Enteral Nutrition
  • Active Comparator: Group 2
    Standard Exclusive Enteral Nutrition for 8 weeks using Modulen, followed by free diet with gradual reduction of Modulen to 25% of energy needs by week 24.
    Interventions:
    • Other: Partial Enteral Nutrition
    • Other: Standard Exclusive Enteral Nutrition
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 1, 2019)
76
Original Estimated Enrollment  ICMJE
 (submitted: July 20, 2016)
40
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Established diagnosis of Crohn's disease.
  2. Patients with mild to severe active Crohn's disease (15≤PCDAI≤47.5)
  3. Ages 8-18
  4. Duration of disease ≤ 36 months
  5. Active inflammation (CRP≥>0.6 mg /dL or ESR≥>20 or Calprotectin≥>200 mcg/gr within the past 3 weeks) during screening
  6. Patients with B1, P0 uncomplicated disease at enrollment
  7. Patients with disease defined as L1, L4, L3 or L2 limited to cecum, ascending or transverse colon or L2 with left sided disease with terminal ileum or small bowel involvement in the past by the Paris classification (patients with macroscopic disease)
  8. Signed informed consent

Exclusion Criteria:

  1. Patients with very mild disease (PCDAI 12.5 -15) or very severe disease (PCDAI >47.5)
  2. Pregnancy
  3. Patients who have disease confined to the colon involving the descending colon, rectum or sigmoid colon and no prior history of small bowel involvement
  4. Patients who have active extra intestinal disease (such as Arthritis, Uveitis, Pyoderma Gangrenosum, Erythema Nodosum etc.)
  5. Patients with complicated disease (B2, B3)
  6. Patients who recently onset use of an immunomodulator <8 weeks, or dose change in past 8 weeks.
  7. Patients with current use of biologics, or use in last 8 weeks or current use of systemic steroids
  8. Patients who have active perianal disease ( active fistula or abscess)
  9. Patients who have positive stool cultures with relevant pathogens,, or positive tests for parasites or C. difficile. Stool tests are mandatory only if diarrhea is present.
  10. Patients with fever > 38.3
  11. Documented milk protein allergy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Arie Levine, MD 972-3-5028808 alevine@wolfson.health.gov.il
Contact: Michal Yaakov pibdr.wmc@gmail.com
Listed Location Countries  ICMJE Canada,   Ireland,   Israel,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02843100
Other Study ID Numbers  ICMJE 0075-16 WOMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Prof. Arie Levine, Wolfson Medical Center
Study Sponsor  ICMJE Prof. Arie Levine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rotem Sigall Boneh, RD Pediatric Gastroenterology and Nutrition unit; The E. Wolfson.Medical Center
Study Director: Michal Yaakov Pediatric Gastroenterology and Nutrition unit; The E. Wolfson.Medical Center
PRS Account Wolfson Medical Center
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP