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

Crohn's Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01728870
• Other study ID #: 0164-12-WOMC
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: July 2018

Study information

• Verified date: July 2018
• Source: Wolfson Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Other:
• Unique Diet+Partial Enteral Nutrition
Modulen - liquid dietary formula
• Exclusive Enteral Nutrition (Modulen)

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
Canada	IWK Health Centre	Halifax	Nova Scotia
Israel	The E. Wolfson.Medical Center	Holon

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Arie Levine

Countries where clinical trial is conducted

Canada,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Response, defined as a drop in PCDAI of 12.5 points or remission, on an intention to treat analysis.		6 weeks
Secondary	Remission at week 6 and week 12 (defined as PCDAI=10, or less than 7.5 without height component),		6 weeks and 12 weeks
Secondary	Bone health	change in serum bone biomarkers from baseline and their correlation with DEXA (optional)	at the 3, and 6 month visits
Secondary	CRP at week 12		12 weeks
Secondary	Physician assessment of compliance		6 weeks