{"type":"trials","record":{"id":56246,"source_id":"clinicaltrials-gov","external_id":"NCT05699148","title":"Gut Imaging for Function and Transit in Cystic Fibrosis 3 Junior","brief_summary":"Recently trial data has shown that the medicine KaftrioTM (Elexacaftor/ Tezacaftor/ Ivacaftor) improves lung function in children aged 6 to 11 years who have cystic fibrosis (CF). This has led to it being licensed for use in the UK in 2022 and is now being prescribed in this age group. There is little information in trials however that shows the effect KaftrioTM (ETI) has on the gut or liver in this age group. Previous studies in the GIFT-CF series (NCT 03566550, NCT04006873 and NCT04618185) has found differences in the functioning of the gut between adults with CF and healthy controls but it is not known whether these differences are present in those aged 6 to 11 years. This study is a significant amendment of the GIFT-CF3 protocol (NCT04618185) that aims to measure gut function using magnetic resonance imaging (MRI) in children with CF before and after starting ETI. This study also aims to opportunistically measure lung function and structure using MRI and explore how the liver can be measured using MRI in this age group. The study is split into 2 stages. The first is a pilot stage using the modified GIFT-CF protocol recruiting 3 children with CF before starting ETI and 3 healthy volunteers. This is to determine we are able to successfully perform these scans in these age groups. If successful, the second stage will recruit a further 12 children with CF before they start ETI. This will take our cohort up to 15 children with CF. This cohort will then be rescanned 6 months after starting ETI using the same scan protocol.","overall_status":"Unknown","phases":[],"study_type":"OBSERVATIONAL","sponsor":"Nottingham University Hospitals NHS Trust","enrollment":17,"countries":["United Kingdom"],"start_date":"2022-04-01","completion_date":"2023-04-01","last_update_date":"2023-01-26","source_url":"https://clinicaltrials.gov/study/NCT05699148","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":"2026-09-25T02:16:44.048862+00:00","last_seen_at":"2026-09-25T06:15:20.281+00:00","metadata":{"sex":"ALL","acronym":"GIFT-CFJunior","age_range":"6 Years to 11 Years","comparator":null,"organization":"Nottingham University Hospitals NHS Trust","interventions":["Elexacaftor / Ivacaftor / Tezacaftor"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Delta Small Bowel Water (DeltaSBW) — This a measure of the change in small bowel water between study time points 240 mi…","Small bowel water content — Will be measured at study timepoints: baseline, 240 minutes and 300 minutes and then area u…","Liver volume — Measured during fasted, baseline MRI scan","Liver elastography — Measured during fasted, baseline MRI scan","Lung ventilation — Measured at 240 minute time point"],"design_description":null,"source_has_results":false},"controlled_terms":["Cystic Fibrosis","Elexacaftor / Ivacaftor / Tezacaftor"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":50,"publication_state":"published","match_explanation":"Title contains controlled term: fibrosis.","quality_checked_at":"2026-09-25T06:15:30.843286+00:00","duplicate_cluster_key":"id:nct05699148","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2022-04-01 to 2023-04-01","comparator":null,"confidence":"structured-source","population":"ALL · 6 Years to 11 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":"2026-09-25T06:15:20.369Z","intervention":["Elexacaftor / Ivacaftor / Tezacaftor"],"participants":17,"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":["Delta Small Bowel Water (DeltaSBW) — This a measure of the change in small bowel water between study time points 240 mi…","Small bowel water content — Will be measured at study timepoints: baseline, 240 minutes and 300 minutes and then area u…","Liver volume — Measured during fasted, baseline MRI scan","Liver elastography — Measured during fasted, baseline MRI scan","Lung ventilation — Measured at 240 minute time point"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"extracellular-matrix-aging","is_published":true,"match_reasons":["Title contains controlled term: fibrosis.","Abstract contains controlled term: fibrosis.","Source terminology contains: fibrosis.","Title supplies longevity context: aging.","Study type is explicitly identified as OBSERVATIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Extracellular matrix ageing","slug":"extracellular-matrix-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/56246","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}