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Partial Enteral Nutrition With a Unique Diet vs. Exclusive Enteral Nutrition for the Treatment of Pediatric Crohn's Disease

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ClinicalTrials.gov Identifier: NCT01728870
Recruitment Status : Completed
First Posted : November 20, 2012
Last Update Posted : July 6, 2018
Information provided by (Responsible Party):
Prof. Arie Levine, Wolfson Medical Center

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 .

Condition or disease Intervention/treatment Phase
Crohn's Disease Other: Unique Diet+Partial Enteral Nutrition Other: Exclusive Enteral Nutrition (Modulen) Not Applicable

Detailed Description:

Background: Crohn's disease is clearly on the rise in countries exposed to industrialization and western diet. Several factors may implicate diet in the pathogenesis of CD or in disease activity. The strongest argument for an effect of diet is the effect of exclusive enteral nutrition (EEN) on disease activity in CD. 40-80% of children , fed an exclusive liquid diet, irrespective of which diet, will enter complete remission, often with normalization of inflammatory markers. The effect of formula has been shown to be independent of fat or protein composition in pediatric studies, but to be dependent on exclusion of normal diet.Thus, rather than the composition of EEN being associated with remission of disease it may be the exclusion of certain components of the Western diet may be responsible for improvement.

Methods:This is a prospective randomized controlled trial, in patients with a recent diagnosis of CD (up to two years),aged 4-18, comparing two arms over 12 weeks of therapy.

Group 1:will receive 50% of their dietary needs from a polymeric formula ( Modulen, Nestle) and a limited whole food diet for 6 weeks/ Group 2: will receive EEN with Modulen for 6 weeks. At the end of 6 weeks, all patients entering remission (irrespective of randomization) will enter the second 6 week phase, continuing 25 % of calories as Modulen in both groups. Patients in remission from group 2 will continue to consume 25% of calories as Modulen and be allowed free diet , patients in Group 1 will continue 25% of calories from Modulen but continue restricted diet.

Patients will be seen at onset (week 0), weeks 3 and 6, 12 and 24 weeks.

We hypothesize that by withdrawing the offending dietary agents we can achieve an equal remission rate with improved tolerability. This study will evaluate response, remission and tolerability in both groups, as well as the effects of nutrition on bone health.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Partial Enteral Nutririon (Modulen) With a Unique Diet to Exclusive Enteral Nutrition (Modulen) for the Treatment of Pediatric Crohn's Disease. A Prospective Randomized Controlled Trial.
Study Start Date : January 2013
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: Unique Diet+Partial Enteral Nutrition

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
Modulen - liquid dietary formula
Other Name: Modulen, Nestle

Active Comparator: Exclusive Enteral Nutrition (Modulen)

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)
Other Name: Modulen, Nestle

Primary Outcome Measures :
  1. patient's adherence with the diet assessed by cessation of therapy because of patients refusal to continue and by a MARS questionnaire [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Response, defined as a drop in PCDAI of 12.5 points or remission, on an intention to treat analysis. [ Time Frame: 6 weeks ]
  2. Remission at week 6 and week 12 (defined as PCDAI≤10, or less than 7.5 without height component), [ Time Frame: 6 weeks and 12 weeks ]
  3. Bone health [ Time Frame: at the 3, and 6 month visits ]
    change in serum bone biomarkers from baseline and their correlation with DEXA (optional)

  4. CRP at week 12 [ Time Frame: 12 weeks ]
  5. Physician assessment of compliance [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Children 4-18 years of age.
  2. Patients with a diagnosis of CD-duration of disease up to 36 months
  3. Have macroscopic small bowel involvement, or isolated large bowel disease confined to the right or transverse colon
  4. Patients with a pediatric activity index -PCDAI ≥ 10
  5. 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.
  6. Informed Consent

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01728870

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Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 1C9
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
The E. Wolfson.Medical Center
Holon, Israel, 58100
Sponsors and Collaborators
Prof. Arie Levine
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Principal Investigator: Arie Levine, MD Pediatric Gastroenterology and Nutrition unit, Wolfson MC
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Arie Levine, Director, Pediatric Gastroenterology and Nutrition unit., Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT01728870    
Other Study ID Numbers: 0164-12-WOMC
First Posted: November 20, 2012    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Keywords provided by Prof. Arie Levine, Wolfson Medical Center:
Crohn's disease
Mild to moderate Crohn's Disease
Enteral Nutrition
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases