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Could a gut bacteria transplant save lungs from sepsis?

NCT ID NCT07342205

Disease control Sponsor: Shanghai University of Traditional Chinese Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether transplanting healthy gut bacteria (fecal microbiota) can help people with acute lung injury caused by sepsis. Sepsis triggers severe inflammation that often damages the lungs, and current treatments are limited. The trial will compare standard care plus a placebo against standard care plus the bacteria transplant in 60 adults. Researchers will measure oxygen levels, survival at 28 days, and ICU stay length.

What this could mean

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

Active substance
human-derived active intestinal bacterial liquid (fecal microbiota transplant)
What this could lead to
If it works, this could offer a new treatment to reduce deaths and improve recovery in sepsis patients with lung injury.
What could go wrong
This is an early phase 2/3 trial with only 60 people. The treatment may not work better than placebo, and risks like infection or gut issues are possible.

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

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 60 people

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

Started

Dec 2025

Expected to finish

Jun 2027

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 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Age ≥ 18 years; * Clear or suspected infection + SOFA score ≥ 2 points, and PaO₂/FiO₂ ≤ 300 mmHg; * Capable of taking in nutrients (able to eat independently or receive enteral nutrition); * Voluntarily participate in this trial and sign the informed consent form. Exclusion Criteria: * Indications for exclusion from FMT (Fecal Microbiota Transplantation) include massive gastrointestinal bleeding, intestinal obstruction, organic intestinal disorders, and severe damage to intestinal mucosa; * Individuals with severe immune deficiencies, such as those with AIDS, leukemia, and those using immunosuppressive drugs; * Pregnant women and lactating women; * Those who cannot undergo nasal-intestinal catheterization or other transplantation methods; * Patients who cannot cooperate to complete the study; Other situations where the researchers determine that a patient is not suitable for participating in the clinical trial.

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Conditions

The condition(s) this trial relates to.

acute lung injury acute respiratory distress syndrome adult acute respiratory distress syndrome

As listed by the trial registrant

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

Acute lung injury(ALI) Acute respiratory distress syndrome (ARDS) Sepsis related acute lung injury/acute respiratory distress syndrome

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Putuo Hospital, Shanghai University of Traditional Chinese Medicine

    RECRUITING

    Shanghai, Putuo, 421000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.