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Gut bacteria capsules may shield heart surgery patients from organ damage

NCT ID NCT04444362

Disease control Sponsor: Nanjing Medical University 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving patients capsules containing gut bacteria (called Probacine) before and after heart surgery can reduce gut injury and organ failure. Researchers will enroll 500 adults undergoing cardiovascular surgery. The goal is to see if changing the gut microbiome can improve recovery and lower death rates.

What this could mean

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

Active substance
Intestinal Microbiota Transplant (IMT) Capsules
What this could lead to
If it works, this could point toward a simple way to protect the gut and organs after heart surgery, reducing complications.
What could go wrong
This is an early-stage trial with no phase designation, so results are uncertain. The intervention involves transplanting gut bacteria, which carries unknown risks.

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

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 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 90 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: * Adult men and women; * Cardiovascular surgery; * Agree to participate in the study and sign the informed consent form. Exclusion Criteria: * Pregnant women; * Patients with preexisting psychotic disorders; * Decline to participate in the study.

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder

As listed by the trial registrant

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

Cardiopulmonary bypass Cardiovascular disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Anzhen Hospital

    Beijing, Beijing Municipality, China

  • Shanghai East Hospital, Tongji University

    Shanghai, China

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210029, China

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, China

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