Accelerating Recovery After ICU Admission: Post-discharge Supplementation With Pasteurized Akkerm… (NCT07295353) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Accelerating Recovery After ICU Admission: Post-discharge Supplementation With Pasteurized Akkermansia Muciniphila.
50 participantsStarted 2026-01
Plain-language summary
The goal of this clinical trial is to learn if daily oral supplementation with pasteurized Akkermansia muciniphila (PAM), an EFSA-approved food supplement, can support recovery in adults who have recently been treated in the ICU for sepsis.
The main questions it aims to answer are:
* Is PAM safe to take for 56 days after ICU discharge?
* Does PAM increase the abundance of beneficial butyrate-producing bacteria in the gut?
Researchers will compare PAM to a placebo (a capsule that looks the same but has no active ingredient) to see if PAM improves gut microbiota and immune recovery.
Participants will:
* Take PAM or placebo capsules once daily for 56 days
* Provide stool and blood samples at baseline, day 28, and day 56
* Receive a follow-up phone call about their health 1 year after starting the study
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a specific pasteurized bacteria called Akkermansia muciniphila for people recovering after an ICU stay — is this something worth considering for my situation, given that I've been through a critical illness or sepsis?
2The trial is still listed as 'not yet recruiting,' so when do you think it might actually open for enrollment, and would it make sense for me to revisit this option later in my recovery?
3Since this is listed as Phase NA, what does that mean for how much is already known about the safety of taking this pasteurized bacterial supplement after an ICU stay, and how would that affect your recommendation for me?
4The trial is measuring changes in gut bacteria that produce butyrate — can you explain whether my current gut health or any medications I'm on might make me a good or poor candidate for this kind of microbiome-focused approach?
5Are there standard treatments or existing strategies for Post-Intensive Care Syndrome that you'd recommend I try first, before considering an experimental microbiome intervention like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in abundance of butyrate-producing bacteria
Timeframe: Baseline and day 56
2
Safety (occurrence of adverse events)
Timeframe: Baseline to day 56 (end of intervention)
Trial details
NCT IDNCT07295353
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)