Diet for Induction and Maintenance of Remission and Re-biosis in Crohn's Disease
NCT ID: NCT02843100
Last Updated: 2022-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
63 participants
INTERVENTIONAL
2018-04-10
2022-05-29
Brief Summary
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Detailed Description
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Objectives: To prove that induction of remission and maintenance of remission can be achieved with a new dietary strategy that involves only 2 weeks of EEN with Modulen and 12 weeks of an exclusion diet involving selected table foods.
Methods: Open label randomized controlled pilot trial comparing two weeks of EEN followed by the CDED and Partial Enteral Nutrition (PEN), to 8 weeks of EEN followed by PEN with free diet. The study will include a control group of healthy children for microbiome studies.
Population: Age 8-18 years with mild to severe active Crohn's disease defined as 15≤Pediatric Crohn's Disease Activity Index (PCDAI)\<47.5.
Time frame: The induction of remission phase will last 8 weeks followed by maintenance phase for a period of 24 weeks.
Expected outcomes and significance: If this method proves to be equivalent to EEN, the duration of use of EEN will be only two weeks, allowing more patients access to dietary therapy. More importantly, this study will also evaluate two maintenance strategies and will be the first to evaluate re-biosis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1
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
Modified Exclusive Enteral Nutrition
Two weeks of Exclusive Enteral Nutrition with Modulen
Crohn's Disease Exclusion Diet
a limited whole food diet
Partial Enteral Nutrition
25-50% of Energy from formula
Group 2
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.
Partial Enteral Nutrition
25-50% of Energy from formula
Standard Exclusive Enteral Nutrition
8 weeks of Exclusive Enteral Nutrition
Interventions
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Modified Exclusive Enteral Nutrition
Two weeks of Exclusive Enteral Nutrition with Modulen
Crohn's Disease Exclusion Diet
a limited whole food diet
Partial Enteral Nutrition
25-50% of Energy from formula
Standard Exclusive Enteral Nutrition
8 weeks of Exclusive Enteral Nutrition
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with mild to severe active Crohn's disease (15≤PCDAI≤47.5)
3. Ages 8-18
4. Duration of disease ≤ 36 months
5. Active inflammation (CRP≥\>0.6 mg /dL or ESR≥\>20 or Calprotectin≥\>200 mcg/gr within the past 3 weeks) during screening
6. Patients with B1, P0 uncomplicated disease at enrollment
7. 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)
8. Signed informed consent
Exclusion Criteria
2. Pregnancy
3. Patients who have disease confined to the colon involving the descending colon, rectum or sigmoid colon and no prior history of small bowel involvement
4. Patients who have active extra intestinal disease (such as Arthritis, Uveitis, Pyoderma Gangrenosum, Erythema Nodosum etc.)
5. Patients with complicated disease (B2, B3)
6. Patients who recently onset use of an immunomodulator \<8 weeks, or dose change in past 8 weeks.
7. Patients with current use of biologics, or use in last 8 weeks or current use of systemic steroids
8. Patients who have active perianal disease ( active fistula or abscess)
9. 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.
10. Patients with fever \> 38.3
11. Documented milk protein allergy
8 Years
18 Years
ALL
No
Sponsors
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Prof. Arie Levine
OTHER_GOV
Responsible Party
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Prof. Arie Levine
Director, Pediatric Gastroenterology and Nutrition unit
Principal Investigators
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Rotem Sigall Boneh, RD
Role: PRINCIPAL_INVESTIGATOR
Pediatric Gastroenterology and Nutrition unit; The E. Wolfson.Medical Center
Michal Yaakov
Role: STUDY_DIRECTOR
Pediatric Gastroenterology and Nutrition unit; The E. Wolfson.Medical Center
Locations
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Dr. Eytan Wine,
Edmonton, , Canada
Johan Van Limbergen
Halifax, , Canada
Dr Sally Lawrence
Vancouver, , Canada
Dr. Séamus Hussey
Dublin, , Ireland
The E. Wolfson.Medical Center
Holon, , Israel
Dr. Francisco Javier Martin Carpi
Barcelona, , Spain
Dr. Víctor Manuel Navas López
Málaga, , Spain
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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0075-16 WOMC
Identifier Type: -
Identifier Source: org_study_id
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