{"type":"trials","record":{"id":33720,"source_id":"clinicaltrials-gov","external_id":"NCT07437352","title":"Assessment of the Effects of Probiotic Supplementation on Gut Microbiota Composition and Short-chain Fatty Acid Production in Frail Elderly Patients Receiving Home Enteral Nutrition With an Oligomeric Formula.","brief_summary":"This is an investigator-initiated, spontaneous, non-profit, randomized intervention study with two parallel arms. The study aims to evaluate the effect of a 30-days probiotic supplementation on the composition of the intestinal microbiota (MA) and the production of short-chain fatty acids (SCFAs) in faecal samples of frail elderly patients receiving home enteral nutrition (HEN) with an oligomeric formula. Participants will be monitored for gastrointestinal complications like constipation and diarrhea, and for Clostridium difficile infections.","overall_status":"Completed","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Istituto Nazionale di Ricovero e Cura per Anziani","enrollment":27,"countries":["Italy"],"start_date":"2018-06-21","completion_date":"2024-07-31","last_update_date":"2026-02-27","source_url":"https://clinicaltrials.gov/study/NCT07437352","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":"2026-09-25T01:20:11.953004+00:00","last_seen_at":"2026-09-25T06:10:07.378+00:00","metadata":{"sex":"ALL","acronym":"MICROBIOTA","age_range":"65 Years","comparator":"control arm","organization":"Istituto Nazionale di Ricovero e Cura per Anziani","interventions":["probiotic supplementation"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change in the gut microbiota composition — from the enrolment to the end of study at 30 days","Change in the production of SCFA — from the enrolment to the end of study at 30 days"],"design_description":"RANDOMIZED · PARALLEL · OTHER · NONE","source_has_results":false},"controlled_terms":["Enteral Nutrition","probiotic supplementation"],"relevance_confidence":80,"source_quality_score":100,"freshness_score":85,"publication_state":"published","match_explanation":"Title contains controlled term: gut microbiota.","quality_checked_at":"2026-09-25T06:10:20.034853+00:00","duplicate_cluster_key":"id:nct07437352","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2018-06-21 to 2024-07-31","comparator":"control arm","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":"2026-09-25T06:10:07.459Z","intervention":["probiotic supplementation"],"participants":27,"study_design":"RANDOMIZED · PARALLEL · OTHER · NONE","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 the gut microbiota composition — from the enrolment to the end of study at 30 days","Change in the production of SCFA — from the enrolment to the end of study at 30 days"],"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.","Title supplies longevity context: frail, elderly.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","title context","study type"],"relevance_score":80,"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/33720","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}