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

NCT ID: NCT07295353

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-01-31

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

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

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Pasteurized Akkermansia muciniphila (PAM)

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

Group Type: EXPERIMENTAL

Pasteurized Akkermansia muciniphila

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo Control

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

THE AKKERMANSIA COMPANY

UNKNOWN

Sponsor Role: collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

W. J. Wiersinga, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

JW Wiersinga, Professor

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC

Central Contacts

Duveke de Gaay Fortman, MD

Role: CONTACT

Phone: +31205669111

Email: p.d.e.degaayfortman@amsterdamumc.nl

Rebekka Bout

Role: CONTACT

Phone: +31205669111

Email: r.rebel@amsterdamumc.nl

Other Identifiers

NL-009844

Identifier Type: -

Identifier Source: org_study_id