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

Cure8 trial brief

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

2 min read
Diet and lifestyle Remission Stricture Phase 2 clinical trial Adult patients Clinicians Researchers Patients On Biologics

Why This Matters

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.

Who Should Pay Attention

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.

Study Snapshot

Story typeClinical Reference
Trial phaseNA
Enrollment80 participants
Study statusNot_yet_recruiting
Source depthTrial registry record

What To Know

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.

Keep In Mind

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.

Source Details

Review the original publication for the complete reporting, methods, and context.

Read Original Source
Clinical trial Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
Trial IDNCT07356232
Study typeInterventional
Trial phaseNA
Enrollment80 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedJul 10, 2026, 12:00 AM
Content availableTrial registry record

This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.

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