Partial Enteral Nutrition for Crohn's Disease

(PANDORA Trial)

This trial explores whether combining partial enteral nutrition (PEN), which involves consuming a special formula for part of daily calories, with standard advanced therapy is more effective for individuals with active Crohn's disease than medication alone. Participants may choose to include PEN, drinking a formula called Kate Farms Peptide 1.5 for about 60% of their daily calories for 8 weeks, or continue their usual treatment without it. The trial seeks individuals with confirmed Crohn's disease who plan to start advanced therapy and have active symptoms affecting daily life.

As an unphased trial, this study offers a unique opportunity to explore innovative treatment combinations that could improve quality of life.

The trial does not require you to stop taking your current medications. You can continue taking methotrexate, aminosalicylates, and thiopurines if you've been on a stable dose for at least 8 weeks. However, you cannot start a new medication in the same class as the one you're currently taking, except for a switch from Ustekinumab to anti-IL23 drugs.

Research has shown that the nutritional supplement used in this trial, Kate Farms Peptide 1.5, is generally well-tolerated by people with Crohn's disease. This plant-based nutrition aims to assist those with this condition. Other studies have found that patients using similar partial enteral nutrition (PEN) methods tolerate it well, even during a Crohn's disease flare-up. These studies suggest that this treatment could be safe to use alongside standard therapy in this trial.¹²³⁴⁵

Most treatments for Crohn's disease involve medications like anti-inflammatories, immune system suppressors, or biologics. However, partial enteral nutrition (PEN) is unique because it focuses on dietary management rather than medication. With PEN, participants consume a specialized formula, like Kate Farms Peptide 1.5, for a significant portion of their calories. Researchers are excited about this approach because it may help manage symptoms by reducing gut inflammation through nutritional means, offering a potentially safer and more natural alternative to traditional drug therapies.

Research has shown that partial enteral nutrition (PEN) can benefit people with Crohn's disease. One study found that 80% of patients with complex digestive problems fully recovered using a similar nutrition method. Another study showed that PEN improved the nutritional health of adults during a Crohn's disease flare-up when combined with new treatments. Additionally, PEN has led to remission in up to 70% of children with inflammatory bowel disease (IBD). In this trial, participants in one arm will receive partial enteral nutrition, consuming Kate Farms Peptide 1.5 for 60% of their calories over 8 weeks. These findings suggest that PEN could be a promising addition to standard treatments for Crohn's disease.²³⁵⁶⁷