Could a liquid diet help Crohn's patients get better faster?
NCT ID NCT07356232
First seen Jun 27, 2026 · Last updated Aug 06, 2026 · Updated 3 times
Summary
This study looks at whether adding a special liquid diet (partial enteral nutrition) to standard medication helps people with active Crohn's disease achieve remission without steroids. About 80 participants will choose to either add the diet or not. The main goal is to see if more people on the diet are in remission after 8 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Partial enteral nutrition (Kate Farms Peptide 1.5 formula) plus Crohn's Disease Exclusion Diet
- What this could lead to
- If it works, this could show that combining a special diet with medication is more effective than medication alone for controlling Crohn's disease.
- What could go wrong
- This is a small, non-randomized study, so results may not apply to everyone. The diet is restrictive and may be hard to follow long-term.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Ability to provide informed consent 2. A confirmed diagnosis of Crohn's disease 3. Plan to start one advanced Crohn's Disease therapy (anti-TNF, anti-IL12/IL23, anti-IL23, anti-alpha 4 beta 7, JAK inhibitor). 4. 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 5. Active disease defined by at least one of the criteria from group A AND one from group B. Group A 1. 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, 2. 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 1. Fecal calprotectin at baseline ≥ 300 ug/gr 2. 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) 3. 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) Exclusion Criteria: 1. Pregnancy or breast feeding 2. Presence of an ostomy 3. Previous total colectomy 4. Short gut syndrome from prior surgeries 5. Consuming parenteral nutrition for more than 350 calories per day in the two weeks prior to screening 6. Having been on the Crohn's Disease Exclusion Diet (CDED) in the 2 weeks prior to screening 7. Plan to receive two simultaneously administered advanced therapies 8. 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. 9. Impending need for CD surgery per investigator 10. Symptomatic stricture or stricture inducing bowel dilation (\>3cm) as per local investigator. 11. \>4 very soft or liquid bowel movements per day when feeling well 12. Diabetes mellitus requiring therapy with medication 13. Known allergy to any ingredient in the Kate Farms formula. 14. Unable to complete online surveys 15. Unable to receive shipments of PEN formula. 16. Starting a new medication for Crohn's disease other than steroids in the 8 weeks prior to the screening visit 17. Has not consumed food in the last 6 days prior to screening 18. Starting an accelerated (non-FDA approved) dose of advanced therapy 19. At time of screening, participant is taking both Prednisone and Budesonide 20. Untreated C. difficile infection with the last 8 weeks
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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