Clinical Trial

Accelerating Recovery After ICU Admission: Post-discharge Supplementation With Pasteurized Akkermansia Muciniphila.

Study acronym: PAM-ICU
Not Yet Recruiting
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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
Trial Details
NCT Number NCT07295353
Lead Sponsor Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators: THE AKKERMANSIA COMPANY, ZonMw: The Netherlands Organisation for Health Research and Development
Conditions Sepsis, Post Intensive Care Unit Syndrome, Critical Illness, Microbiome Dysbiosis, Intensive Care Unit Survivors
Enrollment 50 participants
Start Date 2026-01
Primary Completion 2028-01 (estimated)
Study Completion 2028-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-19