Partial Enteral Nutrition for Active Crohn's Disease

This study is looking at whether adding a special liquid diet, called partial enteral nutrition (PEN), to standard advanced medications can help people with active Crohn's disease. Participants will consume Kate Farms Peptide 1.5 for about 60% of their daily calories, along with following the Crohn's Disease Exclusion Diet. You can join if you are starting a new advanced Crohn's therapy (like anti-TNF or anti-IL23 medications) and are between 18 and 80 years old. The main goal is to see how many people achieve steroid-free remission after 8 weeks. This study is currently recruiting 80 participants across 15 sites in the United States.

Study design
This is an open-label study, meaning both you and the study team will know which treatment you are receiving. It is not randomized, so you will choose whether to include PEN or not. The study plans to enroll 80 participants.
What's involved
You would consume Kate Farms Peptide 1.5 for approximately 60% of your calories while following the Crohn's Disease Exclusion Diet. The primary endpoint is measured after 8 weeks of pharmacologic therapy.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured 8 weeks after starting pharmacologic therapy.

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NCT07356232

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

Not Yet Recruiting
NAAges 18–80InterventionalTreatment
University of Pennsylvania
~80 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Partial enteral nutrition - orally consumed formula

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of steroid-free remission following 8 weeks of pharmacologic therapy
Measured over From start of pharmacologic therapy to 8 weeks.
Crohn's Disease, Active
1 sites across 1 states
Pennsylvania1
  • James Lewis, MD, MSCE · PRINCIPAL_INVESTIGATOR · University of Pennsylvania

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  • Rate of steroid-free remission following 8 weeks of pharmacologic therapyFrom 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.