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Could your own gut bacteria restore bowel control after cancer surgery?

NCT ID NCT07711509

Disease control Sponsor: Peking University People's Hospital 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study tests whether transplanting a person's own fecal bacteria into the bowel before ileostomy reversal can improve bowel and anal function after rectal cancer surgery. Participants receive four weekly enemas made from their own stool. The goal is to reduce symptoms like leakage and urgency, which are common after this type of surgery.

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 transplantation (a person's own stool bacteria, processed and given as an enema)
What this could lead to
If it works, this approach could offer a simple, personalized way to reduce bowel control problems and improve quality of life after rectal cancer surgery.
What could go wrong
This is a small, early-stage study with no comparison group, so results may not be generalizable. The procedure may cause discomfort or fail to improve symptoms.

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

35 people

The number who actually took part.

Started

Mar 2025

Expected to finish

Sep 2026

An estimate. End dates often move.

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: 1. Age 18 to 75 years. 2. Histologically or clinically confirmed rectal cancer with the lower tumor margin less than 12 cm from the anal verge. 3. Undergoing radical rectal cancer surgery with protective loop ileostomy. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Able to understand the study procedures and willing to provide written informed consent. Exclusion Criteria: 1. History of inflammatory bowel disease, bacterial colitis, or other preoperative colonic inflammatory disease. 2. Requirement for emergency surgery due to intestinal obstruction, perforation, bleeding, or other emergency conditions. 3. Pregnant or lactating women. 4. Presence of clinically significant gut microbiota dysbiosis before enrollment, as judged by the investigator. 5. Planned postoperative radiotherapy, chemotherapy, or chemoradiotherapy. 6. Poor compliance, inability to tolerate the intervention, or judged by the investigator to be unsuitable for participation in this clinical study. 7. Severe postoperative complications such as anastomotic leakage.

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Conditions

The condition(s) this trial relates to.

diversion colitis Fecal Incontinence Low Anterior Resection Syndrome rectal cancer rectal neoplasm

As listed by the trial registrant

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

Diversion colitis Fecal incontinence Gut microbiota dysbiosis Ileostomy Low anterior resection syndrome Rectal cancer

Contacts and locations

Locations

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044, China

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