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

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

Status: Not yet enrolling

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

Treatments: Other: Placebo Control; Dietary Supplement: Pasteurized Akkermansia muciniphila

Study type: Interventional

Funder types: Other

Identifiers

NCT07295353

NL-009844

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Pasteurized Akkermansia muciniphila (PAM)

Experimental group

Description:

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

Treatment:

Dietary Supplement: Pasteurized Akkermansia muciniphila

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo Control