{"type":"trials","record":{"id":33616,"source_id":"clinicaltrials-gov","external_id":"NCT01218165","title":"Low Grade Inflammation, Gut Microbiota and Barrier Function in Elderly Humans","brief_summary":"Cardiovascular diseases (CVD) are the main cause of death in the European Union. A large part of the aging process, including immunosenescence, is explained by an imbalance between inflammatory and anti-inflammatory networks, wich results in the low grade chronic pro-inflammatory status termed inflammaging. It can contribute to a number of age-related chronic diseases (e.g. atherosclerosis, type 2 diabetes, Alzheimer disease, osteoporosis). Prevention or delay in onset of chronic diseases can potentially benefit a large segment of the elderly population. Now it is hypothesised that a probiotic drink can reduce low-grade inflammation through improvement of the gut barrier function and gut microbiota composition in elderly people with low-grade inflammation.","overall_status":"Completed","phases":["EARLY_PHASE1"],"study_type":"INTERVENTIONAL","sponsor":"Charite University, Berlin, Germany","enrollment":48,"countries":["Germany"],"start_date":"2010-05-01","completion_date":"2011-05-01","last_update_date":"2011-10-28","source_url":"https://clinicaltrials.gov/study/NCT01218165","editorial_summary":"A registered EARLY_PHASE1 study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:20:11.10691+00:00","last_seen_at":"2026-09-25T06:20:19.667+00:00","metadata":{"sex":"MALE","acronym":null,"age_range":"65 Years to 85 Years","comparator":"Control Group","organization":"Charite University, Berlin, Germany","interventions":["Probiotic drink","Control Group"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Pre/post-intervention change in hsCRP — 6 weeks","Intestinal permeability — 6 weeks","Stool: Stool: Real-Time-PCR — 6 weeks","Blood screening — 6 weeks","Muscle function — 6 weeks","Physical performance status — 6 weeks"],"design_description":"RANDOMIZED · PARALLEL · PREVENTION · NONE","source_has_results":false},"controlled_terms":["Aged","Healthy","Probiotic drink","Control Group"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":35,"publication_state":"published","match_explanation":"Title contains controlled term: gut microbiota.","quality_checked_at":"2026-09-25T06:20:27.00315+00:00","duplicate_cluster_key":"id:nct01218165","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2010-05-01 to 2011-05-01","comparator":"Control Group","confidence":"structured-source","population":"MALE · 65 Years to 85 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:20:19.780Z","intervention":["Probiotic drink","Control Group"],"participants":48,"study_design":"RANDOMIZED · PARALLEL · PREVENTION · NONE","subject_scope":"Human clinical study registration","evidence_stage":"EARLY_PHASE1","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Pre/post-intervention change in hsCRP — 6 weeks","Intestinal permeability — 6 weeks","Stool: Stool: Real-Time-PCR — 6 weeks","Blood screening — 6 weeks","Muscle function — 6 weeks","Physical performance status — 6 weeks"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"microbiome-dysbiosis","is_published":true,"match_reasons":["Title contains controlled term: gut microbiota.","Abstract contains controlled term: gut microbiota.","Title supplies longevity context: elderly.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Microbiome and dysbiosis","slug":"microbiome-dysbiosis"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/33616","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}