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

NCT07295353 | Not Yet Recruiting DMC

• 1 other identifier: NL-009844
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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

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

Keywords

Pasteurized Akkermansia muciniphila; Akkermansia muciniphila; Postbioticum; Microbiome; PAM; Gut Barrier Function; Post-Sepsis Recovery; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• Change in abundance of butyrate-producing bacteria

  Difference (Δ) from baseline in the relative abundance of gut butyrate-producing bacteria at day 56, assessed by shotgun metagenomic sequencing (taxa/functional pathways associated with butyrate production), comparing PAM vs placebo at the end of the intervention

  Baseline and day 56

• Safety (occurrence of adverse events)

  Proportion of participants with ≥1 adverse event (AE) and total AE count, summarized by severity and relatedness, comparing PAM vs placebo at end of intervention

  Baseline to day 56 (end of intervention)

Secondary Outcomes (4)

• Changes in gut microbiota composition

  Day 0 (baseline), day 28, day 56

• Changes in circulating immune and inflammatory profiles

  Day 0 (baseline), day 28, day 56

• Changes in gut barrier markers

  Day 0 (baseline), day 28, day 56

• Secondary infections and rehospitalizations

  Through day 365

Other Outcomes (1)

• Host metabolic function

  Day 0 (baseline), day 28, day 56

Study Arms (2)

Pasteurized Akkermansia muciniphila (PAM)

EXPERIMENTAL

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

Dietary Supplement: Pasteurized Akkermansia muciniphila

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo Control

Interventions

Pasteurized Akkermansia muciniphila DIETARY_SUPPLEMENT

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

Pasteurized Akkermansia muciniphila (PAM)

Placebo Control OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Recent major gastrointestinal surgery
• Diagnosed with ulcerative colitis or Crohn's disease
• History of solid organ or stem cell transplantation
• Pregnancy or lactation
• Any other condition that, in the opinion of the investigator, could pose a risk to the subject or interfere with study result

Sponsors & Collaborators

• THE AKKERMANSIA COMPANY: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

MeSH Terms

Conditions

Sepsis; Critical Illness

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• JW Wiersinga, Professor

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Duveke de Gaay Fortman, MD

CONTACT

+31205669111; p.d.e.degaayfortman@amsterdamumc.nl

Rebekka Bout

CONTACT

+31205669111; r.rebel@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind, placebo-controlled trial. Participants, care providers, investigators, and outcomes assessors are masked to intervention assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomized in a parallel-group design to receive either pasteurized Akkermansia muciniphila supplementation or placebo.

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share