Partial Enteral Nutrition as Therapeutic Augmentation of Advanced Pharmacological Therapy in Pati… (NCT07356232) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Partial Enteral Nutrition as Therapeutic Augmentation of Advanced Pharmacological Therapy in Patients With Active Crohn's Disease
United States80 participantsStarted 2026-04
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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,
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of steroid-free remission following 8 weeks of pharmacologic therapy
Timeframe: From start of pharmacologic therapy to 8 weeks.
. 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.
. Fecal calprotectin at baseline ≥ 300 ug/gr
Exclusion criteria
. 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
. Having been on the Crohn's Disease Exclusion Diet (CDED) in the 2 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.