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Could a poop pill save lives? new trial targets superbug lung infections in ICU patients

NCT ID NCT06970262

Disease control Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 03, 2026 · Updated 4 times

Summary

This study tests whether fecal microbiota transplantation (FMT) — transferring healthy donor stool into the gut — can lower the risk of death in ventilated ICU patients with multidrug-resistant lung infections. The idea is that restoring gut bacteria may help fight lung infections through the gut-lung connection. About 60 adults will receive either standard care or standard care plus FMT via a feeding tube, and researchers will track survival at 28 days.

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.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 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 to 70 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 18-70 years, inclusive, irrespective of sex or ethnic background; 2. Admission to the intensive care unit (ICU) within 24-48 hours; 3. Anticipated ICU length of stay of ≥7 days, as determined by the attending intensivist prior to enrollment; 4. Mechanically ventilated patients with MDRO infection; 5. Provision of written informed consent by the participant or legally authorized representative. Exclusion Criteria: 1. Severe systemic infection during early resuscitation, accompanied by hemodynamic instability, profound tissue hypoperfusion, or life-threatening electrolyte and acid-base disturbances; 2. Clinician-assessed high risk of mortality within 5 days, or presence of formal treatment-limiting directives (e.g., do-not-intubate or do-not-resuscitate orders); 3. Active gastrointestinal bleeding or perforation consistent with severe intestinal barrier dysfunction; 4. Inability to tolerate enteral nutrition providing ≥50% of estimated caloric requirements due to structural intestinal pathology-including fibrotic bowel stenosis or high-output enterocutaneous fistula; 5. Planned abdominal surgery or history of abdominal surgery within 14 days prior to enrollment; 6. Confirmed diagnosis of fulminant colitis or toxic megacolon; 7. Neutropenia defined as absolute neutrophil count \< 1.5 × 10⁹/L; 8. Recent exposure to high-risk immunosuppressive or cytotoxic agents within the preceding 3 months, including but not limited to: rituximab (within 6 months), anthracyclines (e.g., doxorubicin), or systemic corticosteroids at ≥20 mg/day prednisone-equivalent dose for ≥4 consecutive weeks; 9. Pregnancy or lactation; 10. Participation in another interventional clinical trial within 3 months prior to enrollment or ongoing at the time of study entry.

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Conditions

The condition(s) this trial relates to.

infectious disease pneumonia

As listed by the trial registrant

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

Food intolerance syndromes Lung infection Microbial colonization

Contacts and locations

Locations

  • Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, China

More trials for these conditions

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