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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Partial Enteral Nutrition as Therapeutic Augmentation of Advanced Pharmacological Therapy in Patients With Active Crohn's Disease
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- James Lewis, MD, MSCE · PRINCIPAL_INVESTIGATOR · University of Pennsylvania
Who to contact
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What this trial measures
- 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.