[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615649":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":25,"responsibleParty":43,"collaborators":46,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":25,"enrollmentInfo":61,"targetDuration":25,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":74,"overallStatus":82,"whyStopped":25,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":25},{"fullName":5,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Dietary Supplement: Pasteurized Akkermansia muciniphila",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Other: Placebo Control",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Pasteurized Akkermansia muciniphila",[9],null,{"type":6,"name":27,"description":17,"armGroupLabels":28,"otherNames":25},"Placebo Control",[15],[30],{"name":31,"affiliation":32,"role":33},"JW Wiersinga, Professor","Amsterdam UMC","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Duveke de Gaay Fortman, MD","CONTACT","+31205669111","p.d.e.degaayfortman@amsterdamumc.nl",{"name":41,"role":37,"phone":38,"phoneExt":25,"email":42},"Rebekka Bout","r.rebel@amsterdamumc.nl",{"type":33,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"W. J. Wiersinga, MD","Professor",[47,50],{"name":48,"class":49},"THE AKKERMANSIA COMPANY","UNKNOWN",{"name":51,"class":6},"ZonMw: The Netherlands Organisation for Health Research and Development","100615649","accelerating-recovery-after-icu-admission-post-discharge-supplementation-with-pasteurized-akkermansia-muciniphila-100615649",false,"NCT07295353","Accelerating Recovery After ICU Admission: Post-discharge Supplementation With Pasteurized Akkermansia Muciniphila.","PAM-ICU","Inclusion Criteria:\n\n* Age ≥18 years\n* Treated in the ICU for at least 2 days and discharged to a regular clinical ward\n* Diagnosed with sepsis during ICU admission\n* Received selective digestive decontamination (SDD) or cephalosporin\n* Capable of giving written informed consent\n\nExclusion Criteria:\n\n* Recent major gastrointestinal surgery\n* Diagnosed with ulcerative colitis or Crohn's disease\n* Presence of a hematological malignancy and\u002For 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.\n* History of solid organ or stem cell transplantation\n* Pregnancy or lactation\n* Donation of blood or plasma within 30 days prior to inclusion or planned donation during the intervention period\n* Any other condition that, in the opinion of the investigator, could pose a risk to the subject or interfere with study result","ALL","18 Years",{"count":62,"type":63},50,"ESTIMATED","INTERVENTIONAL",[66],"NA","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.\n\nThe main questions it aims to answer are:\n\n* Is PAM safe to take for 56 days after ICU discharge?\n* Does PAM increase the abundance of beneficial butyrate-producing bacteria in the gut?\n\nResearchers 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.\n\nParticipants will:\n\n* Take PAM or placebo capsules once daily for 56 days\n* Provide stool and blood samples at baseline, day 28, and day 56\n* Receive a follow-up phone call about their health 1 year after starting the study",[69,70,71,72,73],"Sepsis","Post Intensive Care Unit Syndrome","Critical Illness","Microbiome Dysbiosis","Intensive Care Unit Survivors",[23,75,76,77,78,79,80,81],"Akkermansia muciniphila","Postbioticum","Microbiome","PAM","Gut Barrier Function","Post-Sepsis Recovery","Randomized Controlled Trial","NOT_YET_RECRUITING","2025-12-08",{"date":85,"type":86},"2025-12-19","ACTUAL",{"date":88,"type":63},"2026-01",{"date":90,"type":63},"2028-01",{"name":5,"class":6}]