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NCT07356232 · ClinicalTrials.gov registry record · NA

Partial Enteral Nutrition as Therapeutic Augmentation of Advanced Pharmacological Therapy in Patients With Active Crohn's Disease

A NA study, sponsored by University of Pennsylvania.

Not yet
Registry status
NA
Development phase
80
Enrollment target

NCT07356232: Clinical Trial NA study, sponsored by University of Pennsylvania.

NCT07356232 is a NA study that has not yet begun recruiting, run by University of Pennsylvania. The registered enrollment target is 80 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07356232, a NA study, has not yet begun recruiting, sponsored by University of Pennsylvania.

NOT YET RECRUITING
Registry status
NA
Development phase
80 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • DIETARY_SUPPLEMENT Partial enteral nutrition - orally consumed formula

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2026-08
Est. Completion 2029-04
Phase NA
University of Pennsylvania

1,423 total trials

What is known before NCT07356232 opens enrollment

NCT07356232 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 1 intervention - of which Partial enteral nutrition - orally consumed formula is the first listed.

NCT07356232 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07356232 about?

NCT07356232 is a clinical study titled "Partial Enteral Nutrition as Therapeutic Augmentation of Advanced Pharmacological Therapy in Patients With Active Crohn's Disease". 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 tha...

What is the current status of trial NCT07356232?

This trial is currently not yet recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2026-08. Estimated completion is 2029-04.

What interventions are being tested in trial NCT07356232?

The interventions under investigation include: Partial enteral nutrition - orally consumed formula (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT07356232?

This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07356232's enrollment target sits among peer trials

80 994th of 2000 higher than 941 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07356232, the US trial registry maintained by the National Library of Medicine. NCT07356232 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.