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

NCT07356232 | Not Yet Recruiting

• 1 other identifier: 859860
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter non-randomized prospective open label trial of partial enteral nutrition (PEN) among patients with active Crohn's disease (CD) starting standard of care advanced therapy. Our central hypothesis is that combination therapy of PEN and pharmacologic therapy is more efficacious than pharmacologic therapy alone and can be well-tolerated for patients. Participants will choose to either include PEN along with starting their advanced therapy or will choose not to include PEN. 80 participants will be recruited from 15 sites across the United States.

Conditions

Crohn's Disease, Active

Keywords

partial enteral nutrition; Crohn's disease exclusion diet

Outcome Measures

Primary Outcomes (1)

• Rate of steroid-free remission following 8 weeks of pharmacologic therapy

  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.

  From start of pharmacologic therapy to 8 weeks.

Study Arms (2)

Partial enteral nutrition

EXPERIMENTAL

Participants will consume Kate Farms Peptide 1.5 for 60% of their calories for 8 weeks

Dietary Supplement: Partial enteral nutrition - orally consumed formula

No partial enteral nutrition

NO INTERVENTION

Interventions

Partial enteral nutrition - orally consumed formula DIETARY_SUPPLEMENT

Participants will consume Kate Farms Peptide 1.5 for approximately 60% of their calories while following the Crohn's Disease Exclusion Diet.

Partial enteral nutrition

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide informed consent
• A confirmed diagnosis of Crohn's disease
• Plan to start one advanced Crohn's Disease therapy (anti-TNF, anti-IL12/IL23, anti-IL23, anti-alpha 4 beta 7, JAK inhibitor).
• If taking aminosalyilates, methotrexate or thiopurines, participant must be on a stable does for at least 8 weeks prior to screening. Methotrexate, aminosalicylates and thiopurines are permitted to be continued with the advanced therapy if on stable dose for at least 8 weeks. Methotrexate or thiopurines may be initiated within 1 week of starting the advanced pharmacologic therapy
• Active disease defined by at least one of the criteria from group A AND one from group B.
• Group A
• Short Crohn's Disease Activity Index (sCDAI) score \>175, and if taking corticosteroids, dose cannot exceed 30 mg for prednisone or 9 mg for budesonide,
• sCDAI \< 175 and on 10- 30 mg of prednisone (or 6-9 mg of budesonide) at a stable dose for 2 weeks. Must have experienced worsening of symptoms with attempts to taper to a lower dose of steroids in 3 months prior to screening.
• Group B
• Fecal calprotectin at baseline ≥ 300 ug/gr
• Active disease seen at colonoscopy within 8 weeks of the screening visit. Active disease requires presence of mucosal breaks including either diffuse scattered erosions or at least one ulcer (\>5mm diameter)
• Active disease on cross-sectional imaging (CT scan, MRI or ultrasound) within 8 weeks of the screening visit (evidence of acute inflammation, such as ulceration or bowel wall thickening with restricted diffusion)

You may not qualify if:

• Pregnancy or breast feeding
• Presence of an ostomy
• Previous total colectomy
• Short gut syndrome from prior surgeries
• Consuming parenteral nutrition for more than 350 calories per day in the two weeks prior to screening
• Plan to receive two simultaneously administered advanced therapies
• Planning to start a new medication in the same class as the medication currently taking. This does not include a switch from Ustekinumab to anti-IL23 drugs.
• Impending need for CD surgery per investigator
• Symptomatic stricture or stricture inducing bowel dilation (\>3cm) as per local investigator.
• \>4 very soft or liquid bowel movements per day when feeling well
• Diabetes mellitus requiring therapy with medication
• Known allergy to any ingredient in the Kate Farms formula.
• Unable to complete online surveys
• Unable to receive shipments of PEN formula.
• Starting a new medication for Crohn's disease other than steroids in the 8 weeks prior to the screening visit

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Crohn Disease; Motor Activity

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 21, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)