{"type":"trials","record":{"id":31741,"source_id":"clinicaltrials-gov","external_id":"NCT05859230","title":"Probiotic Intervention on Gut Microbiota and Cognitive Functioning in Older Adults With a Mild Cognitive Impairment","brief_summary":"Recent studies suggest that gut microbiota is linked to cognitive performance and modulating gut microbiota is a safe and promising approach to enhance cognition. The limited studies in the area of probiotics for cognitive impairment in early stages warrant further research. In this feasibility study, we will examine the effects of probiotic consumption in older adults with mild cognitive impairment (MCI), on gut microbiota and cognition via microbiota composition, inflammatory, immune, and bacterial metabolite mechanisms, using neuropsychological tests. The single probiotic contains the Lacticaseibacillus paracasei strain Shirota (LcS), with proven efficacy in various health conditions as well as in stress, sleep, and mood disorders; but to our knowledge, it has not been rigorously examined in early stages of cognitive impairment. After 12 weeks of the randomized, double-blinded probiotic/placebo intervention, we hypothesize that the changes in the composition of gut microbiota, short-chain fatty acids, and the inflammatory/immunological markers, could improve functional connectivity and cognition.","overall_status":"Unknown","phases":[],"study_type":"INTERVENTIONAL","sponsor":"National University of Singapore","enrollment":50,"countries":["Singapore"],"start_date":"2022-08-05","completion_date":"2023-12-01","last_update_date":"2023-05-15","source_url":"https://clinicaltrials.gov/study/NCT05859230","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Unknown. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:16:21.317971+00:00","last_seen_at":"2026-09-25T06:05:41.111+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"60 Years to 90 Years","comparator":"The placebo drink study group","organization":"National University of Singapore","interventions":["Experimental: The probiotic drink study group","Placebo Comparator: The placebo drink study group"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change in composition of gut microbiota after probiotic and placebo intervention — Baseline, 6 weeks, 12 weeks of inter…","Changes in verbal learning and memory function of neurocognitive assessment after probiotic and placebo intervention —…","Changes in attention and verbal working memory function of neurocognitive assessment after probiotic and placebo interv…","Changes in sustained attention and reasoning function by color trails neurocognitive assessment after probiotic and pla…","Changes in sustained attention and reasoning function by Stroop test of neurocognitive assessment after probiotic and p…","Changes in language, lexical knowledge and semantic memory function of neurocognitive assessment after probiotic and pl…","Changes in visuospatial, organizational non-verbal processing function of neurocognitive assessment after probiotic and…","Changes in plasma immune and inflammatory markers after probiotic and placebo intervention — Baseline, 6 weeks, 12 week…","Changes in blood immune and inflammatory markers in-vitro stimulation by toll-like receptors agonists after probiotic a…","Changes in blood cortisol levels after probiotic and placebo intervention — Baseline, 6 weeks, 12 weeks of intervention…","Changes in fecal short-chain fatty acids after probiotic and placebo intervention — Baseline, 6 weeks, 12 weeks of inte…"],"design_description":"RANDOMIZED · PARALLEL · PREVENTION · QUADRUPLE","source_has_results":false},"controlled_terms":["Mild Cognitive Impairment","Experimental: The probiotic drink study group","Placebo Comparator: The placebo drink study group"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":50,"publication_state":"published","match_explanation":"Title contains controlled term: gut microbiota.","quality_checked_at":"2026-09-25T06:05:45.671606+00:00","duplicate_cluster_key":"id:nct05859230","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2022-08-05 to 2023-12-01","comparator":"The placebo drink study group","confidence":"structured-source","population":"ALL · 60 Years to 90 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":"2026-09-25T06:05:41.156Z","intervention":["Experimental: The probiotic drink study group","Placebo Comparator: The placebo drink study group"],"participants":50,"study_design":"RANDOMIZED · PARALLEL · PREVENTION · QUADRUPLE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","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":["Change in composition of gut microbiota after probiotic and placebo intervention — Baseline, 6 weeks, 12 weeks of inter…","Changes in verbal learning and memory function of neurocognitive assessment after probiotic and placebo intervention —…","Changes in attention and verbal working memory function of neurocognitive assessment after probiotic and placebo interv…","Changes in sustained attention and reasoning function by color trails neurocognitive assessment after probiotic and pla…","Changes in sustained attention and reasoning function by Stroop test of neurocognitive assessment after probiotic and p…","Changes in language, lexical knowledge and semantic memory function of neurocognitive assessment after probiotic and pl…","Changes in visuospatial, organizational non-verbal processing function of neurocognitive assessment after probiotic and…","Changes in plasma immune and inflammatory markers after probiotic and placebo intervention — Baseline, 6 weeks, 12 week…","Changes in blood immune and inflammatory markers in-vitro stimulation by toll-like receptors agonists after probiotic a…","Changes in blood cortisol levels after probiotic and placebo intervention — Baseline, 6 weeks, 12 weeks of intervention…","Changes in fecal short-chain fatty acids after probiotic and placebo intervention — Baseline, 6 weeks, 12 weeks of inte…"],"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: older adult.","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/31741","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}