Recruiting
Phase 1
Phase 2

Observational Study

Sponsor:

UCLA

Code:

NCT06461559

Conditions

Stoma Ileostomy

Ileostomy; Complications

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

antegrade infusion of ileostomy content

Study Details

Brief 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.

Conditions

Stoma Ileostomy

Ileostomy; Complications

Study ID

NCT06461559

Start date

Aug 1, 2024

Status verified date

Jun, 2025

Completion date

May 1, 2026

Anticipated

Primary completion date

Mar 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • unable to perform consent
  • unable to perform stoma infusion

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control

active comparator: Ileostomy infusion

perform infusion if ileostomy prior to takedown operation

Interventions

antegrade infusion of ileostomy content

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

Primary outcome measure

  • timing to return of bowel function [ Time Frame: 1-5 days ]

Central Contacts and Locations

Locations

UC San Diego

Recruiting

La Jolla, California, United States, 92093

Contacts

More Information

Sponsor

University of California, San Diego

Last update posted

Dec 15, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2025-12-15.