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RecruitingNCT06461559Updated Dec 15, 2025

Pilot Study of Preoperative Intestinal Training Using Antegrade Ileostomy Infusion

A Phase 1/2 interventional study of antegrade infusion of ileostomy content in Stoma Ileostomy and Ileostomy; Complications, sponsored by University of California, San Diego. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-15.

Sponsored by University of California, San Diego · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started Aug 2024; still recruiting 2 years 2 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This research study is being conducted to study the effect of infusing your contents from your ostomy bag back into your intestine to re-train them prior to the ostomy takedown operation, which is a surgery to reverse your ostomy to put your intestine back together. Because your intestine past the ostomy hasn't seen any intestinal content for several weeks to months before the takedown operation, it is no longer used to handling the daily work of processing intestinal content and will take time to recover its normal function after surgery. We hope to speed up this process by training them before your planned surgery.

02

Conditions studied

  • Stoma Ileostomy
  • Ileostomy; Complications
03

In context

Lead sponsor

University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Has a diverting loop ileostomy
  • undergoing evaluation for stoma takedown

Exclusion criteria

Exclusion Criteria:

  • unable to perform consent
  • unable to perform stoma infusion
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Investigator)
Enrollment
20 participants (estimated)

Study arms

  • No intervention
    Control
  • Active comparator
    Ileostomy infusion

    perform infusion if ileostomy prior to takedown operation

    Device: antegrade infusion of ileostomy content

Interventions

  • Deviceantegrade infusion of ileostomy content

    infusing the contents of ileostomy output back into intestine of the patient

06

What researchers measure

Primary outcomes

  1. timing to return of bowel function

    time to return of bowel function after stoma surgery

    Time frame: 1-5 days

Secondary outcomes

  1. ease of stoma infusion

    how easy was it for patients to infuse contents

    Time frame: 2 weeks prior to surgery to time of surgery

  2. complications

    if there are any complications from using the stoma infusion

    Time frame: 2 weeks prior to surgery to 30 days post operatively

07

Study locations

1 of 1 sites recruiting
  • UC San Diego
    La Jolla, California 92093, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06461559
Lead sponsor
University of California, San Diego
Responsible party
Shanglei Liu (Assistant Professor of Surgery, University of California, San Diego) — Principal investigator
First posted
Jun 17, 2024
Start date
Aug 1, 2024
Primary completion
Mar 1, 2026 (estimated)
Completion
May 1, 2026 (estimated)
Last update
Dec 15, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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