Crohn's Disease, ActivePANDORANCT07356232
Partial Enteral Nutrition as Therapeutic Augmentation of Advanced Pharmacological Therapy in Patients With Active Crohn's Disease
A study testing Partial enteral nutrition - orally consumed formula in people with Crohn's Disease, Active, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn's Disease, Active
- What is being tested?
- Partial enteral nutrition - orally consumed formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
- Has not consumed food in the last 6 days prior to screening
- Starting an accelerated (non-FDA approved) dose of advanced therapy
- At time of screening, participant is taking both Prednisone and Budesonide
- Untreated C. difficile infection with the last 8 weeks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Research Coordinator
DCC Project Manager, nessel@pennmedicine.upenn.edu
About this study
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
- Being tested
- Partial enteral nutrition - orally consumed formula
- Keywords
- partial enteral nutrition, Crohn's disease exclusion diet
- Medical subject headings
- Crohn Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial enteral nutrition - orally consumed formulaDietary supplement
Participants will consume Kate Farms Peptide 1.5 for approximately 60% of their calories while following the Crohn's Disease Exclusion Diet.
| Study group | Role | What they receive |
|---|---|---|
| Partial enteral nutrition | Experimental | Participants will consume Kate Farms Peptide 1.5 for 60% of their calories for 8 weeks Receives: Dietary Supplement: Partial enteral nutrition - orally consumed formula |
| No partial enteral nutrition | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From start of pharmacologic therapy to 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study startSep 2026 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's Disease, ActiveStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Lewis, MD, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356232
- Sponsor's protocol ID
- 859860
- Acronym
- PANDORA
- Status last verified
- Aug 2026
- First submitted
- 12 Jan 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Enteral Nutrition as Therapeutic Augmentation of Advanced Pharmacological Therapy in Patients With Active Crohn's Disease
- ClinicalTrials.gov ID
- NCT07356232
- Acronym / sponsor ID
- PANDORA / 859860
- Conditions
- Crohn's Disease, Active
- Keywords
- partial enteral nutrition, Crohn's disease exclusion diet
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partial enteral nutrition | Experimental | Dietary Supplement: Partial enteral nutrition - orally consumed formulaParticipants will consume Kate Farms Peptide 1.5 for 60% of their calories for 8 weeks |
| No partial enteral nutrition | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partial enteral nutrition - orally consumed formulaParticipants will consume Kate Farms Peptide 1.5 for approximately 60% of their calories while following the Crohn's Disease Exclusion Diet. | Dietary supplement | Partial enteral nutrition |
Primary outcome
Rate of steroid-free remission following 8 weeks of pharmacologic therapy
Time frame: From start of pharmacologic therapy to 8 weeks.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James Lewis, MD, MSCE principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partial enteral nutrition - orally consumed formula in people with Crohn's Disease, Active, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raksha Shastry (267-896-3160, Raksha.Shastry@PennMedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of steroid-free remission following 8 weeks of pharmacologic therapy (time frame: From start of pharmacologic therapy to 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.