Stoma IleostomyPhase 1/2NCT06461559
Pilot Study of Preoperative Intestinal Training Using Antegrade Ileostomy Infusion
A Phase 1/2 study testing antegrade infusion of ileostomy content in people with Stoma Ileostomy and Ileostomy; Complications, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stoma Ileostomy, Ileostomy; Complications
- What is being tested?
- antegrade infusion of ileostomy content
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 1 May 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a diverting loop ileostomy
- undergoing evaluation for stoma takedown
Who cannot join
- unable to perform consent
- unable to perform stoma infusion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UC San Diego
La Jolla, California, 92093
Shanglei Liu, 858-249-1837, ssgaboyan@health.ucsd.edu
About this study
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
- Being tested
- antegrade infusion of ileostomy content
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antegrade infusion of ileostomy contentDevice
infusing the contents of ileostomy output back into intestine of the patient
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Ileostomy infusion | Active comparator | perform infusion if ileostomy prior to takedown operation Receives: Device: antegrade infusion of ileostomy content |
What is being measured
The primary outcome is the main question the study is designed to answer.
timing to return of bowel function
time to return of bowel function after stoma surgery
Measured: 1-5 days
Secondary outcomes (2)
ease of stoma infusion
how easy was it for patients to infuse contents
Measured: 2 weeks prior to surgery to time of surgery
complications
if there are any complications from using the stoma infusion
Measured: 2 weeks prior to surgery to 30 days post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Aug 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stoma IleostomyStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shanglei Liu, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461559
- Sponsor's protocol ID
- 810144
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2024
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Preoperative Intestinal Training Using Antegrade Ileostomy Infusion
- ClinicalTrials.gov ID
- NCT06461559
- Acronym / sponsor ID
- 810144
- Conditions
- Stoma Ileostomy, Ileostomy; Complications
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Ileostomy infusion | Active comparator | Device: antegrade infusion of ileostomy contentperform infusion if ileostomy prior to takedown operation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Has a diverting loop ileostomy
- undergoing evaluation for stoma takedown
Key exclusion criteria (2 listed)
- unable to perform consent
- unable to perform stoma infusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antegrade infusion of ileostomy contentinfusing the contents of ileostomy output back into intestine of the patient | Device | Ileostomy infusion |
Primary outcome
timing to return of bowel function
Time frame: 1-5 days
time to return of bowel function after stoma surgery
2 secondary outcomes
ease of stoma infusion
Time frame: 2 weeks prior to surgery to time of surgery
complications
Time frame: 2 weeks prior to surgery to 30 days post operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing antegrade infusion of ileostomy content in people with Stoma Ileostomy and Ileostomy; Complications, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
timing to return of bowel function (time frame: 1-5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.