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

July 3, 2018 updated by: Prof. Arie Levine

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.

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1C9
        • University of Alberta
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • IWK Health Centre
  • Israel
      • Holon, Israel, 58100
        • The E. Wolfson.Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Modulen, Nestle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response, defined as a drop in PCDAI of 12.5 points or remission, on an intention to treat analysis.
Time Frame: 6 weeks
6 weeks
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
6 weeks and 12 weeks
Bone health
Time Frame: at the 3, and 6 month visits
change in serum bone biomarkers from baseline and their correlation with DEXA (optional)
at the 3, and 6 month visits
CRP at week 12
Time Frame: 12 weeks
12 weeks
Physician assessment of compliance
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Arie Levine

Investigators

  • Principal Investigator: Arie Levine, MD, Pediatric Gastroenterology and Nutrition unit, Wolfson MC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

November 13, 2012

First Submitted That Met QC Criteria

November 19, 2012

First Posted (Estimate)

November 20, 2012

Study Record Updates

Last Update Posted (Actual)

July 6, 2018

Last Update Submitted That Met QC Criteria

July 3, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0164-12-WOMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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