Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:08 AM
Study NCT ID:
NCT07356232
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-25
First Post:
2026-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Partial Enteral Nutrition as Therapeutic Augmentation of Advanced Pharmacological Therapy in Patients With Active Crohn's Disease
Sponsor:
University of Pennsylvania
Organization:
Study Overview
Official Title:
Partial Enteral Nutrition as Therapeutic Augmentation of Advanced Pharmacological Therapy in Patients With Active Crohn's Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PANDORA
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: