{"type":"trials","record":{"id":33979,"source_id":"clinicaltrials-gov","external_id":"NCT01303484","title":"The Effect of Prebiotic B-GOS on the Immune Function, Metabolism and Gut Microbiota of Elderly People","brief_summary":"The purpose of this study is to determine the effects of prebiotic B-GOS on the immune function, metabolism and gut microbiota of elderly people","overall_status":"Completed","phases":["EARLY_PHASE1"],"study_type":"INTERVENTIONAL","sponsor":"Clasado","enrollment":40,"countries":["United Kingdom"],"start_date":"2011-05-01","completion_date":"2014-07-01","last_update_date":"2016-03-25","source_url":"https://clinicaltrials.gov/study/NCT01303484","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":"2026-09-25T01:20:11.953004+00:00","last_seen_at":"2026-09-25T06:15:06.064+00:00","metadata":{"sex":"ALL","acronym":"PRIMES","age_range":"65 Years to 80 Years","comparator":"MDn; B-GOS","organization":"Clasado","interventions":["Bi2muno® GOS","Maltodextrin"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Effect of B-GOS on immunity by measuring various inflammatory/immune biomarkers — 12 months","Effect of B-GOS on the faecal microbiota composition of elderly persons — 12 months","Effect of aging on body metabolites using NMR — 12 months","Effect of B-GOS on gut permeability — 12 months","Weekly assessment of stools and gastrointestinal symptoms — 8 months"],"design_description":"RANDOMIZED · CROSSOVER · TREATMENT · TRIPLE","source_has_results":false},"controlled_terms":["Immunosenescence","Bi2muno® GOS","Maltodextrin"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":35,"publication_state":"published","match_explanation":"Title contains controlled term: gut microbiota.","quality_checked_at":"2026-09-25T06:15:09.632521+00:00","duplicate_cluster_key":"id:nct01303484","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2011-05-01 to 2014-07-01","comparator":"MDn; B-GOS","confidence":"structured-source","population":"ALL · 65 Years to 80 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":"2026-09-25T06:15:06.095Z","intervention":["Bi2muno® GOS","Maltodextrin"],"participants":40,"study_design":"RANDOMIZED · CROSSOVER · TREATMENT · TRIPLE","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":["Effect of B-GOS on immunity by measuring various inflammatory/immune biomarkers — 12 months","Effect of B-GOS on the faecal microbiota composition of elderly persons — 12 months","Effect of aging on body metabolites using NMR — 12 months","Effect of B-GOS on gut permeability — 12 months","Weekly assessment of stools and gastrointestinal symptoms — 8 months"],"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/33979","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}