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Pilot Study of Partial Enteral Nutrition With a Unique Diet for the Treatment of Adult Patients With Crohn's Disease (CDED-ADULTS)

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ClinicalTrials.gov Identifier: NCT02231814
Recruitment Status : Recruiting
First Posted : September 4, 2014
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Arie Levine, Wolfson Medical Center

August 27, 2014
September 4, 2014
September 14, 2018
December 2016
December 2019   (Final data collection date for primary outcome measure)
Clinical remission defined as Harvey Bradshaw Index (HBI)<5 [ Time Frame: Week 6 ]
Clinical remission defined as HBI<4 . [ Time Frame: Week 6 ]
Complete list of historical versions of study NCT02231814 on ClinicalTrials.gov Archive Site
  • Steroid free remission [ Time Frame: Week 6, 12 and 24. ]
  • Mucosal healing- Normal colonoscopy or normal MRE with normal calprotectin [ 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 ]
  • 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 ]
Not Provided
Not Provided
 
Pilot Study of Partial Enteral Nutrition With a Unique Diet for the Treatment of Adult Patients With Crohn's Disease
Dietary Therapy Using Partial Enteral Nutrition and the Crohn's Disease Exclusion Diet (CDED) for Induction and Maintenance of Remission in Mild to Moderate Crohn's Disease in Adults- A Pilot Study
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Crohn's Disease
  • 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
  • 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
Sigall-Boneh R, Pfeffer-Gik T, Segal I, Zangen T, Boaz M, Levine A. Partial enteral nutrition with a Crohn's disease exclusion diet is effective for induction of remission in children and young adults with Crohn's disease. Inflamm Bowel Dis. 2014 Aug;20(8):1353-60. doi: 10.1097/MIB.0000000000000110.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
20
December 2019
December 2019   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Israel
 
 
NCT02231814
0105-14
No
Not Provided
Not Provided
Prof. Arie Levine, Wolfson Medical Center
Prof. Arie Levine
Not Provided
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
Wolfson Medical Center
September 2018

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