Partial Enteral Nutrition as Therapeutic Augmentation of Advanced Pharmacological Therapy in Patients With Active Crohn's Disease
Adding structured partial enteral nutrition to advanced drug therapy could offer a non-pharmacologic way to improve short-term, steroid-free remission rates in active Crohn's disease if the trial shows benefit.
Patients and clinicians interested in diet-based adjuncts to biologics would find the question directly relevant.
Adults with active Crohn's disease, clinicians treating Crohn's disease, researchers in IBD nutrition and treatment augmentation, and patients considering combining diet-based approaches with advanced therapies.
What To Know
This registered clinical trial is testing whether adding partial enteral nutrition (PEN) to standard advanced pharmacologic therapy helps people with active Crohn's disease achieve steroid-free remission at 8 weeks. This is a multicenter, non-randomized, prospective open-label interventional study that will recruit about 80 adults across 15 US sites.
Participants choose to add PEN — consuming Kate Farms Peptide 1.5 to provide ~60% of calories while following the Crohn's Disease Exclusion Diet — or to start pharmacologic advanced therapy without PEN. The main outcome is the rate of steroid-free clinical remission at week 8 defined by short CDAI and steroid dose limits.
The study is listed as not yet recruiting and is not randomized; participants select whether to include PEN, which may affect comparisons between groups.
The protocol excludes people with ostomies, recent CDED use, short-gut or high prior parenteral nutrition, certain surgical needs or symptomatic strictures, diabetes on therapy, pregnancy, and other criteria.
Adults with active Crohn's disease considering dietary strategies alongside biologics or other advanced therapies, gastroenterology clinicians, and researchers studying nutritional augmentation of IBD treatment. This is a trial registry entry (not results).
It is non-randomized and open-label, so any eventual findings will need careful interpretation for bias and generalizability. The intervention uses a specific commercial formula (Kate Farms Peptide 1.5) plus the Crohn's Disease Exclusion Diet.
This is a registered, not-yet-recruiting interventional study and does not report results. The study is non-randomized and participants choose whether to take PEN, which can introduce selection bias. The protocol specifies a particular commercial formula and the Crohn's Disease Exclusion Diet; applicability to other formulas or diets is uncertain.
