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Could a daily 'Good Bacteria' capsule speed up recovery after sepsis?

NCT ID NCT07295353

Disease control Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a daily capsule of pasteurized Akkermansia muciniphila, a type of beneficial gut bacteria, can help adults recover after being treated for sepsis in the ICU. Fifty participants will take either the supplement or a placebo for 56 days. Researchers will check safety and measure changes in gut bacteria and immune markers from stool and blood samples.

What this could mean

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

Active substance
Pasteurized Akkermansia muciniphila (a beneficial gut bacteria) taken as a daily capsule
What this could lead to
If it works, this could point toward a simple, safe supplement to help people recover their gut health and immune function after a serious ICU stay for sepsis.
What could go wrong
This is a very early, small study (50 people) testing safety and gut bacteria changes, not whether it actually improves recovery. The supplement may have no effect or cause side effects.

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 50 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

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

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: * Age ≥18 years * Treated in the ICU for at least 2 days and discharged to a regular clinical ward * Diagnosed with sepsis during ICU admission * Received selective digestive decontamination (SDD) or cephalosporin * Capable of giving written informed consent Exclusion Criteria: * Recent major gastrointestinal surgery * Diagnosed with ulcerative colitis or Crohn's disease * Presence of a hematological malignancy and/or current use of immunomodulatory therapy (e.g., CAR-T cell therapy or immune checkpoint inhibitors) Use of systemic immunomodulatory drugs or corticosteroids (defined as ≥10 mg prednisone equivalent daily at ICU discharge), at the time of inclusion. * History of solid organ or stem cell transplantation * Pregnancy or lactation * Donation of blood or plasma within 30 days prior to inclusion or planned donation during the intervention period * Any other condition that, in the opinion of the investigator, could pose a risk to the subject or interfere with study result

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Conditions

The condition(s) this trial relates to.

Critical Illness infectious disease with sepsis Sepsis

As listed by the trial registrant

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

Critical illness Intensive care unit survivors Microbiome dysbiosis Post intensive care unit syndrome Sepsis

How to take part

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  1. 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 ↗

  2. A doctor treating you

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More trials for these conditions

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