Diet for Induction and Maintenance of Remission and Re-biosis in Crohn's Disease

NCT02843100 | Completed

• 1 other identifier: 0075-16 WOMC
• Study Type: interventional
• Target: 63
• Locations: 4 countries
• Sites: 7

Brief Summary

The modified-Exclusive Enteral Nutrition (mEEN) is an open label randomized controlled trial in mild to severe Crohn's Disease patients. The purpose of this study is to determine whether induction of remission and maintenance of remission can be achieved with a new dietary strategy that involves only 2 weeks of Exclusive Enteral Nutrition (EEN) with Modulen and 12 weeks of an exclusion diet involving selected table foods. This novel approach will be compared to the gold standard dietary regime involving 8 weeks of EEN.

Conditions

Crohn's Disease

Keywords

Crohn's Disease; Pediatric; Exclusive Enteral Nutrition; Diet; Microbiome

Outcome Measures

Primary Outcomes (1)

• ITT, steroid free Clinical remission (defined as Pediatric Crohn's Disease Activity Index (PCDAI)<10) at week 14

  Sustained remission with EEN Vs CDED+PEN

  week 14

Secondary Outcomes (6)

• ITT steroid free remission at week 8

  week 8

• Microbiome composition difference between groups at week 14

  week 14

• 3. Reduction of at least 50% from baseline in fecal calprotectin at week 24 for patients on original treatment

  week 24

• Steroid and biologic free sustained remission at week 24.

  week 14 and 24

• Need for additional treatment to achieve remission by week 14

  Week 14

Study Arms (2)

Group 1

EXPERIMENTAL

Modified Exclusive Enteral Nutrition including two weeks of Exclusive Enteral Nutrition (EEN) using Modulen followed by Partial Enteral Nutrition (PEN) along with the Crohn's Disease Exclusion Diet (CDED) phases 2 \& 3 for 24 weeks

Other: Modified Exclusive Enteral Nutrition; Other: Crohn's Disease Exclusion Diet; Other: Partial Enteral Nutrition

Group 2

ACTIVE COMPARATOR

Standard Exclusive Enteral Nutrition for 8 weeks using Modulen, followed by free diet with gradual reduction of Modulen to 25% of energy needs by week 24.

Other: Partial Enteral Nutrition; Other: Standard Exclusive Enteral Nutrition

Interventions

Modified Exclusive Enteral Nutrition OTHER

Two weeks of Exclusive Enteral Nutrition with Modulen

Also known as: Modulen, Nestle

Group 1

Crohn's Disease Exclusion Diet OTHER

a limited whole food diet

Also known as: CDED

Group 1

Partial Enteral Nutrition OTHER

25-50% of Energy from formula

Also known as: Modulen, Nestle

Group 1; Group 2

Standard Exclusive Enteral Nutrition OTHER

8 weeks of Exclusive Enteral Nutrition

Also known as: Modulen, Nestle

Group 2

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Established diagnosis of Crohn's disease.
• Patients with mild to severe active Crohn's disease (15≤PCDAI≤47.5)
• Ages 8-18
• Duration of disease ≤ 36 months
• Active inflammation (CRP≥\>0.6 mg /dL or ESR≥\>20 or Calprotectin≥\>200 mcg/gr within the past 3 weeks) during screening
• Patients with B1, P0 uncomplicated disease at enrollment
• Patients with disease defined as L1, L4, L3 or L2 limited to cecum, ascending or transverse colon or L2 with left sided disease with terminal ileum or small bowel involvement in the past by the Paris classification (patients with macroscopic disease)
• Signed informed consent

You may not qualify if:

• Patients with very mild disease (PCDAI 12.5 -15) or very severe disease (PCDAI \>47.5)
• Pregnancy
• Patients who have disease confined to the colon involving the descending colon, rectum or sigmoid colon and no prior history of small bowel involvement
• Patients who have active extra intestinal disease (such as Arthritis, Uveitis, Pyoderma Gangrenosum, Erythema Nodosum etc.)
• Patients with complicated disease (B2, B3)
• Patients who recently onset use of an immunomodulator \<8 weeks, or dose change in past 8 weeks.
• Patients with current use of biologics, or use in last 8 weeks or current use of systemic steroids
• Patients who have active perianal disease ( active fistula or abscess)
• Patients who have positive stool cultures with relevant pathogens,, or positive tests for parasites or C. difficile. Stool tests are mandatory only if diarrhea is present.
• Patients with fever \> 38.3
• Documented milk protein allergy

Sponsors & Collaborators

• Prof. Arie Levine: lead

Study Sites (7)

Dr. Eytan Wine,

Edmonton, Canada

Location

Johan Van Limbergen

Halifax, Canada

Location

Dr Sally Lawrence

Vancouver, Canada

Location

Dr. Séamus Hussey

Dublin, Ireland

Location

The E. Wolfson.Medical Center

Holon, 58100, Israel

Location

Dr. Francisco Javier Martin Carpi

Barcelona, Spain

Location

Dr. Víctor Manuel Navas López

Málaga, Spain

Location

Related Publications (4)

• 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

• Levine A, Wine E, Assa A, Sigall Boneh R, Shaoul R, Kori M, Cohen S, Peleg S, Shamaly H, On A, Millman P, Abramas L, Ziv-Baran T, Grant S, Abitbol G, Dunn KA, Bielawski JP, Van Limbergen J. Crohn's Disease Exclusion Diet Plus Partial Enteral Nutrition Induces Sustained Remission in a Randomized Controlled Trial. Gastroenterology. 2019 Aug;157(2):440-450.e8. doi: 10.1053/j.gastro.2019.04.021. Epub 2019 Jun 4.

  PMID: 31170412 BACKGROUND

• Sigall Boneh R, Sarbagili Shabat C, Yanai H, Chermesh I, Ben Avraham S, Boaz M, Levine A. Dietary Therapy With the Crohn's Disease Exclusion Diet is a Successful Strategy for Induction of Remission in Children and Adults Failing Biological Therapy. J Crohns Colitis. 2017 Oct 1;11(10):1205-1212. doi: 10.1093/ecco-jcc/jjx071.

  PMID: 28525622 BACKGROUND

• Sigall Boneh R, Navas-Lopez VM, Hussey S, Pujol-Muncunill G, Lawrence S, Rolandsdotter H, Otley A, Martin-de-Carpi J, Abramas L, Herrador-Lopez M, Egea Castillo N, Chen M, Hurley M, Wingate K, Olen O, Eurenius Raaf T, Yaakov M, Wierdsma N, Van Limbergen J, Wine E. Modified Crohn's Disease Exclusion Diet Maintains Remission in Pediatric Crohn's Disease: Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2025 Oct;23(11):2001-2011. doi: 10.1016/j.cgh.2024.12.006. Epub 2024 Dec 26.

  PMID: 39732356 DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Rotem Sigall Boneh, RD

  Pediatric Gastroenterology and Nutrition unit; The E. Wolfson.Medical Center

  PRINCIPAL INVESTIGATOR

• Michal Yaakov

  Pediatric Gastroenterology and Nutrition unit; The E. Wolfson.Medical Center

  STUDY DIRECTOR

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: June 22, 2016
• First Posted: July 25, 2016
• Study Start: April 10, 2018
• Primary Completion: May 29, 2022
• Study Completion: May 29, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1); ES (2); CA (3); IE (1)