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

• Register: ClinicalTrials.gov
• Last refreshed on: 6 June 2022
• Main ID: NCT02231814
• Date of registration: 27/08/2014
• Prospective Registration: Yes
• Primary sponsor: Prof. Arie Levine
• Public title: The Crohn's Disease Exclusion Diet With Partial Enteral Nutrition or Alone in Adult Patients With Crohn's Disease CDED-AD
• Scientific title: 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
• Date of first enrolment: December 2016
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02231814
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Israel

Contacts

• Name: Iris Dotan, MD
• Affiliation: Tel Aviv Medical Center

• Name: Arie Levine, MD
• Affiliation: Wolfson Medical Center

• Name: Irit Hermesh, MD
• Affiliation: Rambam Medical Center,Haifa

Key inclusion & exclusion 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

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Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Other: Crohns Disease Exclusion Diet

Dietary Supplement: Crohns Disease Exclusion Diet + PEN

Primary Outcome(s)

Clinical remission defined as Harvey Bradshaw Index (HBI)<5 [Time Frame: Week 6]

Secondary Outcome(s)

Change in mean fecal calprotectin [Time Frame: Week 6, 12 and 24]

Changes in mean C-Reactive Protein (CRP) [Time Frame: Weeks 6, 12 and 24.]

Mucosal healing [Time Frame: Week 24-26]

Steroid free remission between groups [Time Frame: Week 6, 12 and 24.]

Secondary ID(s)

0105-14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors