[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06617013":3,"trial-entities:NCT06617013":89,"trial-summary:NCT06617013":94},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":35,"secondary_outcomes":46,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":15,"eligibility_criteria":50,"std_ages":59,"locations":62,"central_contacts":78,"overall_officials":83,"references":87,"see_also_links":88},"NCT06617013","PRO00115374","GERD in Children With Cystic Fibrosis","Characteristics of Gastroesophageal Reflux in Children With Cystic Fibrosis","RECRUITING","2026-06-30","2025-12","2025-12-19","2024-10-23","Duke University","OTHER",false,"The purpose of this study is to evaluate the prevalence of gastroesophageal reflux disease (GERD) symptoms in pediatric patients with cystic fibrosis using the Gastroesophageal Symptom Assessment Scale (GSAS) and the impact of stopping anti-GERD therapy on the GERD symptoms reported.",null,[19,20],"GERD in Children","Cystic Fibrosis in Children",[],"INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},20,"ESTIMATED",[30],{"type":14,"name":31,"description":32,"armGroupLabels":33},"Discontinuation of GERD therapy","GERD therapy will be discontinued at time of enrollment.",[34],"Child with cystic fibrosis (CF) on GERD therapy without severe GERD",[36,40,44],{"measure":37,"description":38,"timeFrame":39},"Change from baseline in the mean GSAS score (only if GERD medication discontinued)","The Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) is a 15-item tool validated in children in assessing gastroesophageal reflux disease-related symptoms. The GSAS ranges from 0 to 490, with a higher score representing worse GERD symptoms, and a score ≥ 15 reflects significant GERD symptoms.","baseline and 12 weeks",{"measure":41,"description":42,"timeFrame":43},"Mean GSAS score in children with CF on GERD therapy","GSAS ranges from 0 to 490, with a higher score representing worse GERD symptoms, and a score ≥ 15 reflects significant GERD symptoms. A value of 80 will be used as a maximum cut-off for mild symptoms as this was 2 SD from the mean GSAS for children without baseline GERD.","Baseline",{"measure":45,"description":42,"timeFrame":43},"Mean GSAS score in children with CF not on GERD therapy",[],"ALL","2 Years","18 Years",{"inclusion":51,"exclusion":54,"raw_text":58},[52,53],"Children 2-18 years of age with a confirmed CF diagnosis by either a positive sweat test or 2 disease causing CFTR mutations.","Signed consent",[55,56,57],"Declining to participate in the study or sign consent","History of severe GERD per gastroenterology diagnosis and documentation","GSAS score \\>80","Inclusion Criteria:\n\n* Children 2-18 years of age with a confirmed CF diagnosis by either a positive sweat test or 2 disease causing CFTR mutations.\n* Signed consent\n\nExclusion Criteria:\n\n* Declining to participate in the study or sign consent\n* History of severe GERD per gastroenterology diagnosis and documentation\n* GSAS score \\>80",[60,61],"CHILD","ADULT",[63],{"facility":64,"status":8,"city":65,"state":66,"zip":67,"country":68,"contacts":69,"geoPoint":75},"Duke University Hospital","Durham","North Carolina","27710","United States",[70],{"name":71,"role":72,"phone":73,"email":74},"Yara Salameh, MF","CONTACT","919-684-8111","yara.salameh@duke.edu",{"lat":76,"lon":77},35.99403,-78.89862,[79,80],{"name":71,"role":72,"phone":73,"email":74},{"name":81,"role":72,"email":82},"Shatha Yousef, MD","shatha.yousef@duke.edu",[84],{"name":85,"affiliation":64,"role":86},"Shatha Yousef","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":90,"biomarkers":93},[91,92],"Cystic Fibrosis","Gastroesophageal Reflux Disease",[],{"nct_id":4,"found":95,"summary":96,"prompt_version":105},true,{"design":97,"status":98,"heading":6,"summary":99,"follow_up":100,"word_count":101,"commitments":102,"compensation":103,"drugs_mentioned":104},"This is an interventional study planning to enroll 20 participants. It will look at the impact of stopping GERD therapy.","completed","This study is looking at children with cystic fibrosis (CF) to understand how common gastroesophageal reflux disease (GERD) symptoms are. Researchers will use a survey called the Gastroesophageal Symptom Assessment Scale (GSAS) to measure these symptoms. For some children already taking GERD medicine, this study will look at what happens to their symptoms if they stop taking that medicine. To join, children must be between 2 and 18 years old with a confirmed CF diagnosis. Children with severe GERD or a very high GSAS score cannot participate. The study aims to enroll 20 children, but its current status is unclear.","Participants will be followed for 12 weeks after enrollment.",100,"Participants will have their GERD therapy discontinued at the time of enrollment. Symptoms will be assessed at baseline and 12 weeks.","Not stated in the trial record.",[],"v2"]