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The Crohn's Disease Exclusion Diet With Partial Enteral Nutrition or Alone in Adult Patients With Crohn's Disease (CDED-AD)

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ClinicalTrials.gov Identifier: NCT02231814
Recruitment Status : Completed
First Posted : September 4, 2014
Last Update Posted : April 14, 2021
Sponsor:
Information provided by (Responsible Party):
Prof. Arie Levine, Wolfson Medical Center

Tracking Information
First Submitted Date  ICMJE August 27, 2014
First Posted Date  ICMJE September 4, 2014
Last Update Posted Date April 14, 2021
Actual Study Start Date  ICMJE December 2016
Actual Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2016)
Clinical remission defined as Harvey Bradshaw Index (HBI)<5 [ Time Frame: Week 6 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 1, 2014)
Clinical remission defined as HBI<4 . [ Time Frame: Week 6 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2021)
  • Steroid free remission between groups [ Time Frame: Week 6, 12 and 24. ]
  • Mucosal healing [ Time Frame: Week 24-26 ]
  • Changes in mean C-Reactive Protein (CRP) [ Time Frame: Weeks 6, 12 and 24. ]
  • Change in mean fecal calprotectin [ Time Frame: Week 6, 12 and 24 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2014)
  • Steroid free remission [ Time Frame: Week 6, 12 and 24. ]
  • Mucosal healing- Normal colonoscopy of normal MRE with normal calprotectin [ Time Frame: Week 24-26 ]
  • Changes in mean CRP [ Time Frame: Weeks 6, 12 and 24. ]
  • Change in mean fecal calprotectin [ Time Frame: Week 6, 12 and 24 ]
  • Change in mean and ESR [ Time Frame: Weeks 6, 12 and 24 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Crohn's Disease Exclusion Diet With Partial Enteral Nutrition or Alone in Adult Patients With Crohn's Disease
Official Title  ICMJE Dietary Therapy Using the Crohn's Disease Exclusion Diet (CDED) With Partial Enteral Nutrition or Alone for Induction and Maintenance of Remission in in Adults With Mild to Moderate Crohn's Disease- A Pilot Study
Brief Summary This study will evaluate a novel diet for adult crohn's disease patients (The Crohn's Disease Exclusion Diet - CDED). Half of the patients in this study will receive the CDED alone while the other half will receive the CDED and a liquid diet formula, for 24 weeks.
Detailed Description

Environmental factors, the microbiome (bacteria in our gut) and innate immunity all play a role in the pathogenesis of Crohn's disease .Exclusive enteral nutrition (EEN) was found to be effective for inducing remission in active pediatric Crohn's disease, while Partial Enteral Nutrition (PEN) with free diet was not; suggesting that the mechanism of EEN depends on exclusion of dietary components. Dietary factors may play a role in the pathogenesis of the disease, and maybe an important under-investigated therapeutic target.

"The Crohn's Disease Exclusion Diet" (CDED) is a palatable diet excluding components suspected to interfere with the bacteria in our gut or impair immune mechanisms. Our group previously evaluated 47 patients using the Crohn's disease Exclusion Diet + 50% Polymeric formula for 6 weeks, and demonstrated a 78% response rate and 70% disease remission rate using stringent criteria. This was accompanied by a highly significant reduction in markers for inflammation (C-reactive protein (CRP) and Erythrocyte Sedimentation Rate (ESR)), and normalization of CRP in 70% of those entering remission. Among these patients were 13 adults aged 19-32, the remission rate in these 13 patients was 69%, similar to the pediatric data. Importantly, 6/7 patients in this study who refused to drink formula and just used the diet achieved remission, suggesting that the exclusion and not partial enteral nutrition are responsible for the high remission rate. Our former study did not evaluate mucosal healing as an end point, since performing colonoscopies after 6- 12 weeks of therapy is neither ethical nor feasible in children.

At present, data about nutritional therapy and this new dietary approach have been generated primarily in children, and this new diet has not been evaluated for early mucosal healing. The objectives of this pilot study are to generate data in adults, evaluate the diet over a longer period of time (24 weeks) and evaluate mucosal healing. The study is a prospective open label randomized controlled pilot trial in adults, with mild to moderate Crohn's disease who will receive the Crohn's Disease Exclusion Diet (CDED) for 24 weeks.

If effective, this could enable use of a feasible, safe intervention for induction and maintenance of remission as a new therapy or as an adjunctive therapy with medical therapy.

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
  • Dietary Supplement: Crohns Disease Exclusion Diet + PEN
    Patients will use the CDED for a 24 week period, coupled with 1000 m"l of polymeric formula (1 Kcal/m"L) for the first 6 weeks. For weeks 7 to 24 patients will use the CDED coupled with 600 ml formula and a calcium supplement. The CDED is divided into 3 stages: 0-6 weeks induction phase, weeks 7-12 step down phase, weeks 13-24 maintenance phase.
    Other Name: CDED + Liquid dietary formula
  • Other: Crohns Disease Exclusion Diet
    Crohn's Disease Exclusion Diet alone with a calcium supplement during the study (0-24). The CDED is divided into 3 stages: 0-6 weeks induction phase, weeks 7-12 step down phase, weeks 13-24 maintenance phase.
    Other Name: CDED
Study Arms  ICMJE
  • Experimental: Group 1
    Crohn's Disease Exclusion Diet+Partial Enteral Nutrition (PEN): Crohns Disease Exclusion Diet + PEN
    Intervention: Dietary Supplement: Crohns Disease Exclusion Diet + PEN
  • Experimental: Group 2
    Crohn's Disease Exclusion Diet alone with a calcium supplement
    Intervention: Other: Crohns Disease Exclusion Diet
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 Completed
Actual Enrollment  ICMJE
 (submitted: July 28, 2016)
40
Original Estimated Enrollment  ICMJE
 (submitted: September 1, 2014)
20
Actual Study Completion Date  ICMJE December 2020
Actual Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  1. Informed consent
  2. Established Crohn's disease
  3. Aged 18-55
  4. Duration of disease up to 5 years
  5. Harvey Bradshaw Index 5 ≤( HBI) ≤15
  6. Patients with uncomplicated disease involving the terminal ileum and or cecum
  7. Patients who performed colonoscopy (or MR/CTEnterography with elevated calprotectin>200) demonstrating active disease in the previous 8 weeks

Exclusion Criteria

  1. Patients with severe Disease (HBI > 15) or HBI<5
  2. Pregnancy,
  3. Patients with active extraintestinal disease, current B2 (Fixed non inflammatory stricture1 or small bowel obstruction) or B3 disease,
  4. Patients who used immunomodulator <8 weeks, or had dose changed in past 8 weeks,
  5. Patients with current or past use of biologics, or use of systemic steroids2,
  6. Patients with deep ulcers involving the colon distal to the splenic flexure on most recent colonoscopy
  7. Any proven current infection such as positive stool cultures or positive tests for parasites or C. difficile. Stool tests are mandatory only if diarrhea is present.
  8. Active Perianal disease ( clarification-fistula with discharge or abscess)
  9. Patients who have undergone an intestinal resection
  10. Patients with systemic disease including: type 2 diabetes, kidney failure, liver failure, neurological disease, active heart disease and patients with active autoimmune condition requiring medication3
  11. Patients unwilling to consume any animal source protein (eggs, chicken or fish).

Comments:

  1. Patients with ileo-cecal valve narrowing maybe included
  2. Patients active despite budesonide may enter the trial if they are on 3 mg, and stop budesonide within 14 days of commencement of the trial.
  3. Patients with Celiac disease or Hashimoto Thyroiditis can be enrolled

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02231814
Other Study ID Numbers  ICMJE 0105-14
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Arie Levine, Wolfson Medical Center
Study Sponsor  ICMJE Prof. Arie Levine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arie Levine, MD Wolfson Medical Center
Principal Investigator: Iris Dotan, MD Tel Aviv Medical Center
Principal Investigator: Irit Hermesh, MD Rambam Medical Center,Haifa
PRS Account Wolfson Medical Center
Verification Date April 2021

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