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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Wolfson Medical Center
Sponsor:
Information provided by (Responsible Party):
Prof. Arie Levine, Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01728870
First received: November 13, 2012
Last updated: April 6, 2014
Last verified: December 2012
  Purpose

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 Intervention Phase
Crohn's Disease
Other: Unique Diet+Partial Enteral Nutrition
Other: Exclusive Enteral Nutrition (Modulen)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Wolfson Medical Center:

Primary Outcome Measures:
  • patient's adherence with the diet captured by a MARS questionnaire [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response, defined as a drop in PCDAI of 12.5 points or remission, on an intention to treat analysis. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Bone health [ Time Frame: at the 3, and 6 month visits ] [ Designated as safety issue: No ]
    change in serum bone biomarkers from baseline and their correlation with DEXA (optional)

  • CRP at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: January 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   4 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01728870

Contacts
Contact: Arie Levine, MD 972-3-5028808 alevine@wolfson.health.gov.il

Locations
Israel
The E. Wolfson.Medical Center Recruiting
Holon, Israel, 58100
Contact: Arie Levine, MD    972-3-5028808    alevine@wolfson.health.gov.il   
Principal Investigator: Arie Levine, MD         
Sponsors and Collaborators
Prof. Arie Levine
Investigators
Principal Investigator: Arie Levine, MD Pediatric Gastroenterology and Nutrition unit, Wolfson MC
  More Information

No publications provided

Responsible Party: Prof. Arie Levine, Director, Pediatric Gastroenterology and Nutrition unit., Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT01728870     History of Changes
Other Study ID Numbers: 0164-12-WOMC
Study First Received: November 13, 2012
Last Updated: April 6, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Wolfson Medical Center:
Pediatric
Crohn's disease
Mild to moderate Crohn's Disease
Diet
Enteral Nutrition

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on August 19, 2014