Crohn's Disease, Active
Conditions
Keywords
partial enteral nutrition, Crohn's disease exclusion diet
Brief summary
This is a multicenter non-randomized prospective open label trial of partial enteral nutrition (PEN) among patients with active Crohn's disease (CD) starting standard of care advanced therapy. Our central hypothesis is that combination therapy of PEN and pharmacologic therapy is more efficacious than pharmacologic therapy alone and can be well-tolerated for patients. Participants will choose to either include PEN along with starting their advanced therapy or will choose not to include PEN. 80 participants will be recruited from 15 sites across the United States.
Interventions
DIETARY_SUPPLEMENTPartial enteral nutrition - orally consumed formula
Participants will consume Kate Farms Peptide 1.5 for approximately 60% of their calories while following the Crohn's Disease Exclusion Diet.
Sponsors
University of Pennsylvania
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Ability to provide informed consent 2. A confirmed diagnosis of Crohn's disease 3. Plan to start one advanced Crohn's Disease therapy (anti-TNF, anti-IL12/IL23, anti-IL23, anti-alpha 4 beta 7, JAK inhibitor). 4. If taking aminosalyilates, methotrexate or thiopurines, participant must be on a stable does for at least 8 weeks prior to screening. Methotrexate, aminosalicylates and thiopurines are permitted to be continued with the advanced therapy if on stable dose for at least 8 weeks. Methotrexate or thiopurines may be initiated within 1 week of starting the advanced pharmacologic therapy 5. Active disease defined by at least one of the criteria from group A AND one from group B. Group A 1. Short Crohn's Disease Activity Index (sCDAI) score \>175, and if taking corticosteroids, dose cannot exceed 30 mg for prednisone or 9 mg for budesonide, 2. sCDAI \< 175 and on 10- 30 mg of prednisone (or 6-9 mg of budesonide) at a stable dose for 2 weeks. Must have experienced worsening of symptoms with attempts to taper to a lower dose of steroids in 3 months prior to screening. Group B 1. Fecal calprotectin at baseline ≥ 300 ug/gr 2. Active disease seen at colonoscopy within 8 weeks of the screening visit. Active disease requires presence of mucosal breaks including either diffuse scattered erosions or at least one ulcer (\>5mm diameter) 3. Active disease on cross-sectional imaging (CT scan, MRI or ultrasound) within 8 weeks of the screening visit (evidence of acute inflammation, such as ulceration or bowel wall thickening with restricted diffusion)
Exclusion criteria
1. Pregnancy or breast feeding 2. Presence of an ostomy 3. Previous total colectomy 4. Short gut syndrome from prior surgeries 5. Consuming parenteral nutrition for more than 350 calories per day in the two weeks prior to screening 6. Having been on the Crohn's Disease Exclusion Diet (CDED) in the 2 weeks prior to screening 7. Plan to receive two simultaneously administered advanced therapies 8. Planning to start a new medication in the same class as the medication currently taking. This does not include a switch from Ustekinumab to anti-IL23 drugs. 9. Impending need for CD surgery per investigator 10. Symptomatic stricture or stricture inducing bowel dilation (\>3cm) as per local investigator. 11. \>4 very soft or liquid bowel movements per day when feeling well 12. Diabetes mellitus requiring therapy with medication 13. Known allergy to any ingredient in the Kate Farms formula. 14. Unable to complete online surveys 15. Unable to receive shipments of PEN formula. 16. Starting a new medication for Crohn's disease other than steroids in the 8 weeks prior to the screening visit 17. Has not consumed food in the last 6 days prior to screening 18. Starting an accelerated (non-FDA approved) dose of advanced therapy 19. At time of screening, participant is taking both Prednisone and Budesonide 20. Untreated C. difficile infection with the last 8 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of steroid-free remission following 8 weeks of pharmacologic therapy | From start of pharmacologic therapy to 8 weeks. | Steroid-free clinical remission at Visit 5 (week 8) of pharmacologic therapy initiation will be defined as a short Crohn's Disease Activity Index (sCDAI) \< 150 points while off steroids. The need to switch therapies, increase or initiate corticosteroids or any other CD drug will be considered as a failure to achieve the primary outcome. |
Countries
United States
Contacts
CONTACTRaksha Shastry
PRINCIPAL_INVESTIGATORJames Lewis, MD, MSCE
University of Pennsylvania
Outcome results
None listed