Accelerating Recovery After ICU Admission: Post-discharge Supplementation With Pasteurized Akkermansia Muciniphila.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Change in abundance of butyrate-producing bacteria
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This is a double-blind, placebo-controlled trial. Participants, care providers, investigators, and outcomes assessors are masked to intervention assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in abundance of butyrate-producing bacteria
时间窗: Baseline and day 56
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
Safety (occurrence of adverse events)
时间窗: Baseline to day 56 (end of intervention)
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
次要结局
- 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)
研究者
W. J. Wiersinga, MD
Professor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)