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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 : December 13, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Crohn's Disease Dietary Supplement: Crohns Disease Exclusion Diet + PEN Other: Crohns Disease Exclusion Diet

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Group 1
Crohn's Disease Exclusion Diet+Partial Enteral Nutrition (PEN): Crohns Disease Exclusion Diet + PEN
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
Experimental: Group 2
Crohn's Disease Exclusion Diet alone with a calcium supplement
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


Outcome Measures

Primary Outcome Measures :
  1. Clinical remission defined as Harvey Bradshaw Index (HBI)<5 [ Time Frame: Week 6 ]

Secondary Outcome Measures :
  1. Steroid free remission [ Time Frame: Week 6, 12 and 24. ]
  2. Mucosal healing- Normal colonoscopy or normal MRE with normal calprotectin [ Time Frame: Week 24-26 ]
  3. Changes in mean C-Reactive Protein (CRP) [ Time Frame: Weeks 6, 12 and 24. ]
  4. Change in mean fecal calprotectin [ Time Frame: Week 6, 12 and 24 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations

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): NCT02231814


Locations
Israel
Wolfson Medical Center Recruiting
Holon, Israel
Contact: Arie Levine, MD    +972-35028878    alevine@wolfson.health.gov.il   
Principal Investigator: Arie Levine, MD         
Sponsors and Collaborators
Prof. Arie Levine
Investigators
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
More Information

Publications:
Responsible Party: Prof. Arie Levine, Director, Pediatric Gastroenterology and Nutrition unit., Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT02231814     History of Changes
Other Study ID Numbers: 0105-14
First Posted: September 4, 2014    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016

Keywords provided by Prof. Arie Levine, Wolfson Medical Center:
Crohn's disease
Mild to moderate Crohn's Disease
Diet
Enteral Nutrition

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases