Pilot Study of Preoperative Intestinal Training Using Antegrade Ileostomy Infusion

December 11, 2025 updated by: Shanglei Liu, University of California, San Diego
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • unable to perform consent
  • unable to perform stoma infusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Active Comparator: Ileostomy infusion
perform infusion if ileostomy prior to takedown operation
Device: antegrade infusion of ileostomy content
infusing the contents of ileostomy output back into intestine of the patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
timing to return of bowel function
Time Frame: 1-5 days
time to return of bowel function after stoma surgery
1-5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ease of stoma infusion
Time Frame: 2 weeks prior to surgery to time of surgery
how easy was it for patients to infuse contents
2 weeks prior to surgery to time of surgery
complications
Time Frame: 2 weeks prior to surgery to 30 days post operatively
if there are any complications from using the stoma infusion
2 weeks prior to surgery to 30 days post operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

June 11, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 17, 2024

Study Record Updates

Last Update Posted (Actual)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 810144

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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