Partial Enteral Nutrition as Therapeutic Augmentation of Advanced Pharmacological Therapy in Patients With Active Crohn's Disease
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 80 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether adding partial enteral nutrition (PEN), a liquid nutrition formula, to advanced Crohn's medicines works better than medicine alone. It is for people with active Crohn's disease who are starting an advanced medicine. Participants choose whether to add the formula.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You can understand and agree to take part in the study.
- You have a confirmed diagnosis of Crohn's disease.
- You plan to start one advanced Crohn's medicine from these groups: anti-TNF, anti-IL12/IL23, anti-IL23, anti-alpha 4 beta 7, or JAK inhibitors.
- If you take aminosalicylates, methotrexate, or thiopurines, your dose must be unchanged for at least 8 weeks before screening. Methotrexate or thiopurines may also be started within 1 week of starting the advanced medicine.
- Your disease must meet at least one symptom rule below AND at least one test rule below.
- Symptom rule 1: Your short Crohn's Disease Activity Index (sCDAI), a symptom score, is above 175. If you take steroids, your dose is no more than 30 mg of prednisone or 9 mg of budesonide.
- Symptom rule 2: Your sCDAI is below 175, and you have taken an unchanged dose of 10–30 mg prednisone or 6–9 mg budesonide for 2 weeks. Symptoms got worse when you tried to lower steroids in the past 3 months.
- Test rules: A stool inflammation test called calprotectin is at least 300 ug/g; OR a colonoscopy in the past 8 weeks shows scattered sores or an ulcer larger than 5 mm; OR a CT, MRI, or ultrasound in the past 8 weeks shows active bowel inflammation.
Who can't join
- You are pregnant or breastfeeding; have an ostomy (an opening for bowel waste); had your whole colon removed; or have short gut syndrome from surgery, meaning too little bowel remains to absorb enough nutrients.
- You received more than 350 calories a day through a vein in the past 2 weeks; followed the Crohn's Disease Exclusion Diet in the past 2 weeks; or ate no food in the past 6 days.
- You plan to take two advanced medicines at once, start an accelerated dose not approved by the FDA, or switch to a medicine in the same group. Switching from ustekinumab to an anti-IL23 medicine is allowed.
- You started a new Crohn's medicine other than steroids in the 8 weeks before screening, or you take both prednisone and budesonide at screening.
- The study doctor thinks you need Crohn's surgery soon; you have a narrowed bowel causing symptoms or bowel widening over 3 cm; or you have more than 4 very soft or watery stools a day even when you feel well.
- You have diabetes that needs medicine, or an untreated C. difficile bowel infection within the past 8 weeks.
- You have a known allergy to any ingredient in the Kate Farms nutrition formula.
- You cannot complete online surveys or receive shipments of the nutrition formula.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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
Study sites (1)
PA
- University of Pennsylvania · Philadelphia, PA 19104Research Coordinator · Study contactDCC Project Manager · Study contact · nessel@pennmedicine.upenn.eduJames D. Lewis, MD, MSCE · Principal investigatorMore trials in Philadelphia