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Status:

COMPLETED

The Crohn's Disease Exclusion Diet With Partial Enteral Nutrition or Alone in Adult Patients With Crohn's Disease

Lead Sponsor:

Prof. Arie Levine

Conditions:

Crohn's Disease

Eligibility:

All Genders

18-55 years

Phase:

NA

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 hal...

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 ...

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • Informed consent
  • Established Crohn's disease
  • Aged 18-55
  • Duration of disease up to 5 years
  • Harvey Bradshaw Index 5 ≤( HBI) ≤15
  • Patients with uncomplicated disease involving the terminal ileum and or cecum
  • Patients who performed colonoscopy (or MR/CTEnterography with elevated calprotectin\>200) demonstrating active disease in the previous 8 weeks
  • Exclusion Criteria
  • Patients with severe Disease (HBI \> 15) or HBI\<5
  • Pregnancy,
  • Patients with active extraintestinal disease, current B2 (Fixed non inflammatory stricture1 or small bowel obstruction) or B3 disease,
  • Patients who used immunomodulator \<8 weeks, or had dose changed in past 8 weeks,
  • Patients with current or past use of biologics, or use of systemic steroids2,
  • Patients with deep ulcers involving the colon distal to the splenic flexure on most recent colonoscopy
  • 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.
  • Active Perianal disease ( clarification-fistula with discharge or abscess)
  • Patients who have undergone an intestinal resection
  • 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
  • Patients unwilling to consume any animal source protein (eggs, chicken or fish).
  • Comments:
  • Patients with ileo-cecal valve narrowing maybe included
  • 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.
  • Patients with Celiac disease or Hashimoto Thyroiditis can be enrolled
  • \-

Exclusion

    Key Trial Info

    Start Date :

    December 1 2016

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2020

    Estimated Enrollment :

    40 Patients enrolled

    Trial Details

    Trial ID

    NCT02231814

    Start Date

    December 1 2016

    End Date

    December 1 2020

    Last Update

    June 1 2022

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    Haemek

    Afula, Israel

    2

    Wolfson Medical Center

    Holon, Israel

    3

    Rabin Medical Center

    Petah Tikva, Israel

    4

    Tel Aviv Sourasky Medical Center

    Tel Aviv, Israel