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.
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 .
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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