NCT01728870

Brief Summary

The purpose of this study is to assess the efficacy and tolerability of a novel dietary intervention for early CD based on partial enteral nutrition, and to compare it to the gold standard but difficult to implement dietary intervention- Exclusive enteral nutrition with Modulen .

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

July 6, 2018

Status Verified

July 1, 2018

Enrollment Period

5.5 years

First QC Date

November 13, 2012

Last Update Submit

July 3, 2018

Conditions

Crohn's Disease

Keywords

PediatricCrohn's diseaseMild to moderate Crohn's DiseaseDietEnteral Nutrition

Outcome Measures

Primary Outcomes (1)

  • patient's adherence with the diet assessed by cessation of therapy because of patients refusal to continue and by a MARS questionnaire

    6 weeks

Secondary Outcomes (5)

  • Response, defined as a drop in PCDAI of 12.5 points or remission, on an intention to treat analysis.

    6 weeks

  • Remission at week 6 and week 12 (defined as PCDAI≤10, or less than 7.5 without height component),

    6 weeks and 12 weeks

  • Bone health

    at the 3, and 6 month visits

  • CRP at week 12

    12 weeks

  • Physician assessment of compliance

    6 weeks

Study Arms (2)

Unique Diet+Partial Enteral Nutrition

EXPERIMENTAL

Unique Diet+Partial Enteral Nutrition (PEN): This group will receive as follows: Weeks 1-6: 50% of dietary needs from PEN (Modulen, Nestle) and 50% from a limited whole food diet. Weeks 7-12: 25% of dietary needs from PEN (Modulen, Nestle) and 75% from a limited whole food diet.

Other: Unique Diet+Partial Enteral Nutrition

Exclusive Enteral Nutrition (Modulen)

ACTIVE COMPARATOR

Exclusive Enteral Nutrition(EEN): This group will receive as follows: Weeks 1-6: EEN(100% of dietary needs from Modulen) Weeks 7-12: 25% of dietary needs from Modulen and 75% from a free diet.

Other: Exclusive Enteral Nutrition (Modulen)

Interventions

Unique Diet+Partial Enteral NutritionOTHER

Modulen - liquid dietary formula

Also known as: Modulen, Nestle
Unique Diet+Partial Enteral Nutrition
Exclusive Enteral Nutrition (Modulen)OTHER
Also known as: Modulen, Nestle
Exclusive Enteral Nutrition (Modulen)

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children 4-18 years of age.
  • Patients with a diagnosis of CD-duration of disease up to 36 months
  • Have macroscopic small bowel involvement, or isolated large bowel disease confined to the right or transverse colon
  • Patients with a pediatric activity index -PCDAI ≥ 10
  • Patients will not be excluded if they have received 5ASA or an immunomodulator for \>8 weeks and the dose is stable , or if they start a thiopurine concurrently , as thiopurines are not considered sufficient to induce remission in active disease before 8 weeks as an isolated therapy.
  • Informed Consent

You may not qualify if:

  • Patients with no disease activity ( PCDAI \<10) or severe disease ( PCDAI ≥ 40).
  • Patients who have received corticosteroids of any kind in the previous 4 weeks.
  • Patients who have started an immunomodulator in the previous 8 weeks
  • Any current biological treatment
  • Isolated Large bowel disease ( L2) involving the recto-sigmoid or descending colon
  • Patients with penetrating disease (abscess or fistula)
  • Active Perianal disease
  • Fixed stricture or small bowel obstruction
  • Normal CRP and ESR
  • Active joint disease.
  • Patients who have undergone an intestinal resection.
  • Sclerosing Cholangitis
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Alberta

Edmonton, Alberta, T6G 1C9, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

The E. Wolfson.Medical Center

Holon, 58100, Israel

Location

Related Publications (5)

  • Sigall Boneh R, van der Kruk N, Wine E, Verburgt CM, de Meij TGJ, Lowenberg M, Gecse KB, Wierdsma N, Derikx JPM, de Jonge WJ, D'Haens G, Ghiboub M, Van Limbergen JE. Tryptophan metabolites profile predict remission with dietary therapy in pediatric Crohn's disease. Therap Adv Gastroenterol. 2025 Feb 25;18:17562848251323004. doi: 10.1177/17562848251323004. eCollection 2025.

    PMID: 40012837DERIVED

  • Verburgt CM, Dunn KA, Ghiboub M, Lewis JD, Wine E, Sigall Boneh R, Gerasimidis K, Shamir R, Penny S, Pinto DM, Cohen A, Bjorndahl P, Svolos V, Bielawski JP, Benninga MA, de Jonge WJ, Van Limbergen JE. Successful Dietary Therapy in Paediatric Crohn's Disease is Associated with Shifts in Bacterial Dysbiosis and Inflammatory Metabotype Towards Healthy Controls. J Crohns Colitis. 2023 Jan 27;17(1):61-72. doi: 10.1093/ecco-jcc/jjac105.

    PMID: 36106847DERIVED

  • Ghiboub M, Penny S, Verburgt CM, Boneh RS, Wine E, Cohen A, Dunn KA, Pinto DM, Benninga MA, de Jonge WJ, Levine A, Van Limbergen JE. Metabolome Changes With Diet-Induced Remission in Pediatric Crohn's Disease. Gastroenterology. 2022 Oct;163(4):922-936.e15. doi: 10.1053/j.gastro.2022.05.050. Epub 2022 Jun 7.

    PMID: 35679949DERIVED

  • Sigall Boneh R, Van Limbergen J, Wine E, Assa A, Shaoul R, Milman P, Cohen S, Kori M, Peleg S, On A, Shamaly H, Abramas L, Levine A. Dietary Therapies Induce Rapid Response and Remission in Pediatric Patients With Active Crohn's Disease. Clin Gastroenterol Hepatol. 2021 Apr;19(4):752-759. doi: 10.1016/j.cgh.2020.04.006. Epub 2020 Apr 14.

    PMID: 32302709DERIVED

  • 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: 31170412DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Arie Levine, MD

    Pediatric Gastroenterology and Nutrition unit, Wolfson MC

    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

November 13, 2012

First Posted

November 20, 2012

Study Start

January 1, 2013

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

July 6, 2018

Record last verified: 2018-07

Locations

CA(2)IL(1)