Partial Enteral Nutrition as Therapeutic Augmentation of Advanced Pharmacological Therapy in Patients With Active Crohn's Disease (PANDORA)

University of Pennsylvania

Status

Begins enrollment in 1 month

Conditions

Crohn's Disease, Active

Treatments

Dietary Supplement: Partial enteral nutrition - orally consumed formula

Study type

Interventional

Funder types

Other

Identifiers

NCT07356232

859860

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Ability to provide informed consent
A confirmed diagnosis of Crohn's disease
Plan to start one advanced Crohn's Disease therapy (anti-TNF, anti-IL12/IL23, anti-IL23, anti-alpha 4 beta 7, JAK inhibitor). 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.
Active disease defined by at least one of the criteria from group A AND one from group B.

Group A

Short Crohn's Disease Activity Index (sCDAI) score >1758
sCDAI < 175 and on 10- 30 mg of prednisone (or 6-9 mg of budesonide) at a stable dose for 2 weeks. Stable daily dose of corticosteroids cannot exceed prednisone 30 mg or budesonide 9 mg. Must have experienced worsening of symptoms with attempts to taper to a lower dose of steroids in 3 months prior to screening.

Group B

Fecal calprotectin at baseline ≥ 300 ug/gr
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)
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

Pregnancy or breast feeding
Presence of an ostomy
Previous total colectomy
Short gut syndrome from prior surgeries
Consuming parenteral nutrition for more than 350 calories per day in the two weeks prior to screening
Having been on the Crohn's Disease Exclusion Diet (CDED) in the 2 weeks prior to screening
Plan to receive two simultaneously administered advanced therapies
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.
Impending need for CD surgery per investigator
Symptomatic stricture or stricture inducing bowel dilation as per local investigator.
>4 very soft or liquid bowel movements per day when feeling well
Diabetes mellitus requiring therapy with medication
Known allergy to any ingredient in the Kate Farms formula.
Previous therapy with EEN or PEN for a minimum of two consecutive weeks- defined as over 60% of calories from PEN
Unable to receive shipments of PEN formula.
Starting a new medication for Crohn's disease other than steroids in the 8 weeks prior to the screening visit
Starting an accelerated (non-FDA approved) dose of advanced therapy