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

NCT02231814 | Completed

• 1 other identifier: 0105-14
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

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.

Conditions

Crohn's Disease

Keywords

Crohn's disease; Mild to moderate Crohn's Disease; Diet; Enteral Nutrition

Outcome Measures

Primary Outcomes (1)

• Clinical remission defined as Harvey Bradshaw Index (HBI)<5

  Week 6

Secondary Outcomes (4)

• Steroid free remission between groups

  Week 6, 12 and 24.

• Mucosal healing

  Week 24-26

• Changes in mean C-Reactive Protein (CRP)

  Weeks 6, 12 and 24.

• Change in mean fecal calprotectin

  Week 6, 12 and 24

Study Arms (2)

Group 1

EXPERIMENTAL

Crohn's Disease Exclusion Diet+Partial Enteral Nutrition (PEN): Crohns Disease Exclusion Diet + PEN

Dietary Supplement: Crohns Disease Exclusion Diet + PEN

Group 2

EXPERIMENTAL

Crohn's Disease Exclusion Diet alone with a calcium supplement

Other: Crohns Disease Exclusion Diet

Interventions

Crohns Disease Exclusion Diet + PEN DIETARY_SUPPLEMENT

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.

Also known as: CDED + Liquid dietary formula

Group 1

Crohns Disease Exclusion Diet OTHER

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.

Also known as: CDED

Group 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Arie Levine: lead

Study Sites (4)

Haemek

Afula, Israel

Location

Wolfson Medical Center

Holon, Israel

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Related Publications (2)

• 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.

  PMID: 24983973 BACKGROUND

• Yanai H, Levine A, Hirsch A, Boneh RS, Kopylov U, Eran HB, Cohen NA, Ron Y, Goren I, Leibovitzh H, Wardi J, Zittan E, Ziv-Baran T, Abramas L, Fliss-Isakov N, Raykhel B, Gik TP, Dotan I, Maharshak N. The Crohn's disease exclusion diet for induction and maintenance of remission in adults with mild-to-moderate Crohn's disease (CDED-AD): an open-label, pilot, randomised trial. Lancet Gastroenterol Hepatol. 2022 Jan;7(1):49-59. doi: 10.1016/S2468-1253(21)00299-5. Epub 2021 Nov 2.

  PMID: 34739863 BACKGROUND

MeSH Terms

Conditions

Crohn Disease

Interventions

penclomedine

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Arie Levine, MD

  Wolfson Medical Center

  PRINCIPAL INVESTIGATOR

• Iris Dotan, MD

  Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

• Irit Hermesh, MD

  Rambam Medical Center,Haifa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Pediatric Gastroenterology and Nutrition unit.

Study Record Dates

• First Submitted: August 27, 2014
• First Posted: September 4, 2014
• Study Start: December 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: June 1, 2022

Record last verified: 2022-05

Locations

IL (4)