{"type":"trials","record":{"id":31277,"source_id":"clinicaltrials-gov","external_id":"NCT07251322","title":"Relationship Between Frailty and Gut Microbiota in Older Adults: An Educational Program for Healthy Aging","brief_summary":"The main objective of this pre-experimental study is to describe the relationship between gut microbiota and changes in the degree of frailty in older adults who participated in an educational program. More specifically, the study aims to: determine the gut microbiota profile of community-dwelling older adults, both robust and frail; analyze the effect of a 12-month educational program on gut microbiota; examine the association of gut microbiota with physical function, functional dependency, and physical activity in frail or pre-frail older adults who received the program; investigate its relationship with the risk of malnutrition; relate the gut microbiota profile to quality of life, depressive symptoms, and social support; and, finally, associate gut microbiota with cognitive frailty and sleep quality in this group of older adults who participated in the health promotion educational intervention.","overall_status":"Completed","phases":[],"study_type":"OBSERVATIONAL","sponsor":"University of Cadiz","enrollment":14,"countries":["Spain"],"start_date":"2025-08-25","completion_date":"2025-09-24","last_update_date":"2025-11-26","source_url":"https://clinicaltrials.gov/study/NCT07251322","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:16:21.317971+00:00","last_seen_at":"2026-09-25T06:10:07.378+00:00","metadata":{"sex":"ALL","acronym":"FRAGBIOTA","age_range":"65 Years","comparator":null,"organization":"University of Cadiz","interventions":["Fecal sample collection"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Gut microbiota — At 12 months after the completion of the study","Frailty Index — Day one and at 12 months after the completion of the study","Functional capacity or physical performance — Day one and at 12 months after the completion of the study","Functional dependence — Day one and at 12 months after the completion of the study","Physical activity and sleep patterns — Day one and at 12 months after the completion of the study","Subjective sleep — Day one and at 12 months after the completion of the study","Quality of life assessment — Day one and at 12 months after the completion of the study","Depressive symptoms — Day one and at 12 months after the completion of the study","Social support — Day one and at 12 months after the completion of the study","Cognitive function assessment — Day one and at 12 months after the completion of the study","Risk of malnutrition — Day one and at 12 months after the completion of the study"],"design_description":null,"source_has_results":false},"controlled_terms":["Frailty","Microbiota","Fecal sample collection"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":85,"publication_state":"published","match_explanation":"Title contains controlled term: frailty.","quality_checked_at":"2026-09-25T06:10:20.034853+00:00","duplicate_cluster_key":"id:nct07251322","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2025-08-25 to 2025-09-24","comparator":null,"confidence":"structured-source","population":"ALL · 65 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":"2026-09-25T06:10:07.479Z","intervention":["Fecal sample collection"],"participants":14,"study_design":"OBSERVATIONAL","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":["Gut microbiota — At 12 months after the completion of the study","Frailty Index — Day one and at 12 months after the completion of the study","Functional capacity or physical performance — Day one and at 12 months after the completion of the study","Functional dependence — Day one and at 12 months after the completion of the study","Physical activity and sleep patterns — Day one and at 12 months after the completion of the study","Subjective sleep — Day one and at 12 months after the completion of the study","Quality of life assessment — Day one and at 12 months after the completion of the study","Depressive symptoms — Day one and at 12 months after the completion of the study","Social support — Day one and at 12 months after the completion of the study","Cognitive function assessment — Day one and at 12 months after the completion of the study","Risk of malnutrition — Day one and at 12 months after the completion of the study"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"frailty","is_published":true,"match_reasons":["Title contains controlled term: frailty.","Abstract contains controlled term: frailty.","Source terminology contains: frailty.","Title supplies longevity context: aging, frailty.","Study type is explicitly identified as OBSERVATIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Frailty","slug":"frailty"}},{"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: aging, frailty.","Study type is explicitly identified as OBSERVATIONAL."],"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/31277","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}