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Stool transplants via stoma show promise for treating Post-Surgery colon inflammation

NCT ID NCT07674186

Disease control Sponsor: Yongjian Liao Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This study tests whether giving patients their own stool bacteria through a temporary stoma can reduce inflammation in the unused part of the colon, a condition called diversion colitis. Sixty-six people with rectal cancer who have a temporary ileostomy will receive either a daily fecal bacteria infusion or a saltwater rinse for four weeks. Researchers will measure changes in inflammation using a camera and tissue samples, and track bowel function and quality of life after the stoma is reversed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
autologous fecal microbiota (own stool bacteria)
What this could lead to
If it works, this could offer a simple, drug-free way to treat diversion colitis and improve bowel function after stoma reversal.
What could go wrong
This is a small, early-stage trial with 66 participants. The treatment may not reduce inflammation better than saline, and long-term benefits are unproven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

66 people

The number who actually took part.

Started

Jun 2022

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histopathologically confirmed rectal adenocarcinoma. * Low anterior resection with temporary loop ileostomy. * Age 18-75 years. * Scheduled for ileostomy reversal at 3-6 months after primary surgery. * Endoscopic confirmation of diversion colitis at week 4 post-ileostomy (modified Harig score ≥4, range 0-12). * Written informed consent. Exclusion Criteria: * Neoadjuvant chemoradiotherapy. * Pre-existing inflammatory bowel disease, irritable bowel syndrome, or chronic constipation. * Previous colorectal surgery (other than index surgery). * Active infection requiring systemic antibiotics within 4 weeks before enrollment. * Use of probiotics, prebiotics, or antibiotics within 4 weeks before enrollment. * Severe organ dysfunction (Child-Pugh B/C cirrhosis, end-stage renal disease). * Pregnancy or lactation. * Any condition precluding protocol compliance or outcome assessment.

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Conditions

The condition(s) this trial relates to.

diversion colitis rectum adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diversion colitis

Contacts and locations

Locations

  • Department of Colorectal Surgery, The First People's Hospital of Lin'an District, Hangzhou

    Hangzhou, Zhejiang, 311300, China

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