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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Crohn's Disease, Active
• Intervention / Treatment: Dietary supplement: Partial enteral nutrition - orally consumed formula

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
      • Contact: Research Coordinator
      • Contact: DCC Project Manager; Email: nessel@pennmedicine.upenn.edu
      • Principal Investigator: James D. Lewis, MD, MSCE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Partial enteral nutrition; Participants will consume Kate Farms Peptide 1.5 for 60% of their calories for 8 weeks	Dietary supplement: Partial 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.
No Intervention: No partial enteral nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of steroid-free remission following 8 weeks of pharmacologic therapy	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.	From start of pharmacologic therapy to 8 weeks.

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: January 12, 2026
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: partial enteral nutrition; Crohn's disease exclusion diet
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Behavior; Crohn Disease; Motor Activity
• Other Study ID Numbers: 859860

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No