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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

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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Other: Modified Exclusive Enteral Nutrition Other: Crohn's Disease Exclusion Diet Other: Partial Enteral Nutrition Other: Standard Exclusive Enteral Nutrition Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Modified Exclusive Enteral Nutrition With the Crohn's Disease Exclusion Diet for Induction and Maintenance of Remission and Re-biosis
Actual Study Start Date : April 10, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
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
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

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.
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. ITT steroid free remission at week 8 [ Time Frame: week 8 ]
    Induction of remission

  2. Microbiome composition difference between groups at week 14 [ Time Frame: week 14 ]
    Assessment of microbiome composition and metabolomics

  3. 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

  4. Steroid and biologic free sustained remission at week 24. [ Time Frame: week 14 and 24 ]
    Remission achieved and maintained without additional therapy

  5. Need for additional treatment to achieve remission by week 14 [ Time Frame: Week 14 ]
    Remission achieved without additional therapy

  6. Mucosal healing as assessed by MRE in dietary responsive disease at week 52 [ Time Frame: Week 52 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02843100


Contacts
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Contact: Arie Levine, MD 972-3-5028808 alevine@wolfson.health.gov.il
Contact: Michal Yaakov pibdr.wmc@gmail.com

Locations
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Canada
Dr. Eytan Wine, Not yet recruiting
Edmonton, Canada
Johan Van Limbergen Not yet recruiting
Halifax, Canada
Dr Sally Lawrence Recruiting
Vancouver, Canada
Ireland
Dr. Séamus Hussey Recruiting
Dublin, Ireland
Israel
The E. Wolfson.Medical Center Recruiting
Holon, Israel, 58100
Contact: Arie Levine, MD    972-3-5028808    alevine@wolfson.health.gov.il   
Sub-Investigator: Arie Levine, MD         
Principal Investigator: Rotem Sigall Boneh, RD         
Spain
Dr. Francisco Javier Martin Carpi Recruiting
Barcelona, Spain
Dr. Víctor Manuel Navas López Recruiting
Málaga, Spain
Sponsors and Collaborators
Prof. Arie Levine
Investigators
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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

Publications:
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Responsible Party: Prof. Arie Levine, Director, Pediatric Gastroenterology and Nutrition unit, Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT02843100    
Other Study ID Numbers: 0075-16 WOMC
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
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
Keywords provided by Prof. Arie Levine, Wolfson Medical Center:
Crohn's Disease
Pediatric
Exclusive Enteral Nutrition
Diet
Microbiome
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases