Partial Enteral Nutrition for Crohn's Disease

(PANDORA Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Must be taking: Advanced Crohn's therapy

Disqualifiers: Pregnancy, Ostomy, Total colectomy, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for individuals who can consent, have confirmed Crohn's disease with active symptoms measured by specific criteria, and are starting advanced therapy. They must not be on high doses of steroids or other excluded medications.

Inclusion Criteria

My condition meets at least one requirement from two different groups.

I am part of Group A.

I can understand and agree to the study's details.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive partial enteral nutrition (PEN) along with pharmacologic therapy or pharmacologic therapy alone for 8 weeks

8 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Partial Enteral Nutrition

Trial Overview

The study tests if adding Partial Enteral Nutrition (PEN) to standard pharmacological treatments for Crohn's disease offers more benefits than medication alone. Participants will choose whether to include PEN in their treatment plan.

How Is the Trial Designed?

Group I: Partial enteral nutrition Experimental Treatment 1 Intervention

Participants will consume Kate Farms Peptide 1.5 for 60% of their calories for 8 weeks

Group II: No partial enteral nutrition Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+