An interventional study of Unique Diet+Partial Enteral Nutrition and Exclusive Enteral Nutrition (Modulen) in Crohn's Disease, sponsored by Prof. Arie Levine. Completed at 3 sites in 2 countries. Open to participants aged 4 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-07-06.
Sponsored by Prof. Arie Levine · Not applicable, Interventional, and Treatment
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.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 74 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Prof. Arie Levine is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
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)
Modulen - liquid dietary formula
Also known as: Modulen, Nestle
Also known as: Modulen, Nestle
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
Response, defined as a drop in PCDAI of 12.5 points or remission, on an intention to treat analysis.
Time frame: 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
Bone health
change in serum bone biomarkers from baseline and their correlation with DEXA (optional)
Time frame: at the 3, and 6 month visits
CRP at week 12
Time frame: 12 weeks
Physician assessment of compliance
Time frame: 6 weeks
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Prof. Arie Levine