Partial Enteral Nutrition With a Unique Diet vs. Exclusive Enteral Nutrition for the Treatment of Pediatric Crohn's Disease
Crohn's Disease
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Pediatric, Crohn's disease, Mild to moderate Crohn's Disease, Diet, Enteral Nutrition
Eligibility Criteria
Inclusion Criteria:
- Children 4-18 years of age.
- Patients with a diagnosis of CD-duration of disease up to 36 months
- Have macroscopic small bowel involvement, or isolated large bowel disease confined to the right or transverse colon
- Patients with a pediatric activity index -PCDAI ≥ 10
- 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.
- Informed Consent
Exclusion Criteria:
- Patients with no disease activity ( PCDAI <10) or severe disease ( PCDAI ≥ 40).
- Patients who have received corticosteroids of any kind in the previous 4 weeks.
- Patients who have started an immunomodulator in the previous 8 weeks
- Any current biological treatment
- Isolated Large bowel disease ( L2) involving the recto-sigmoid or descending colon
- Patients with penetrating disease (abscess or fistula)
- Active Perianal disease
- Fixed stricture or small bowel obstruction
- Normal CRP and ESR
- Active joint disease.
- Patients who have undergone an intestinal resection.
- Sclerosing Cholangitis
- Pregnancy
Sites / Locations
- University of Alberta
- IWK Health Centre
- The E. Wolfson.Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Unique Diet+Partial Enteral Nutrition
Exclusive Enteral Nutrition (Modulen)
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.
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.