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

NCT07295353 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-19

No results posted yet for this study

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

Conditions

  • Sepsis
  • Post Intensive Care Unit Syndrome
  • Critical Illness
  • Microbiome Dysbiosis
  • Intensive Care Unit Survivors

Interventions

DIETARY_SUPPLEMENT

Pasteurized Akkermansia muciniphila

Oral supplementation with pasteurized Akkermansia muciniphila, 30 × 10⁹ bacteria in capsule form, once daily for 56 days, in addition to standard care.

OTHER

Placebo Control

Oral administration of placebo capsules matched in appearance and dosing schedule to the PAM capsules, once daily for 56 days, in addition to standard care. The placebo contains no active component.

Sponsors & Collaborators

  • THE AKKERMANSIA COMPANY

    collaborator UNKNOWN

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • JW Wiersinga, Professor · Amsterdam UMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2028-01-31
Completion
2028-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07295353 on ClinicalTrials.gov