[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563414":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":19,"locations":10,"responsibleParty":29,"collaborators":10,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":10,"eligibilityCriteria":37,"healthyVolunteers":33,"sex":38,"minAge":39,"maxAge":40,"enrollmentInfo":41,"targetDuration":10,"studyType":44,"phases":10,"briefSummary":45,"conditions":46,"keywords":10,"overallStatus":49,"whyStopped":10,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":10},{"fullName":5,"class":6},"The Leeds Teaching Hospitals NHS Trust","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients referred for high-resolution oesophageal manometry and multi-channel impedance pH testing",null,"Patients that have been referred for high-resolution oesophageal manometry and multi-channel intraluminal impedance-pH monitoring at the Gastrointestinal Physiology department at Leeds Teaching Hospitals between September 2024 - January 2025 (subject to change based on recruitment time).",[13],"Other: Questionnaire",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"Questionnaire","Two questionnaires will be provided to participants to complete before their routine tests (which they would already be having regardless of the study and are not affected by their participation in the study).\n\nThe questionnaires include: A Gastro-Oesophageal Reflux Symptom Questionnaire; and the ROME-IV Diagnostic IBS Module Questionnaire",[9],[20,25],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"Kate Brownley, MSc Clinical Science","CONTACT","+441132064268","kate.brownley@nhs.net",{"name":26,"role":22,"phone":27,"phoneExt":10,"email":28},"Ella Moore, BSc Human Physiology","+447736564456","ella.moore5@nhs.net",{"type":30,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100563414","the-influence-of-concomitant-irritable-bowel-syndrome-on-gastro-oesophageal-reflux-disease-symptoms-and-severity-100563414",false,"NCT06615856","The Influence of Concomitant Irritable Bowel Syndrome on Gastro-Oesophageal Reflux Disease Symptoms and Severity.","Understanding the Influence of Concomitant Irritable Bowel Syndrome (IBS) on Gastro-Oesophageal Reflux Disease (GORD), Including GORD-related Symptoms, GORD Severity, Oesophageal Motility, and Multi-Channel Intraluminal Impedance-pH Findings.","Inclusion Criteria:\n\n* Patients that have been referred for high-resolution oesophageal manometry and ambulatory pH or multichannel intraluminal impedance-pH (MII-pH) studies at the Gastrointestinal Physiology department at Leeds Teaching Hospitals NHS Trust from September 2024 to January 2025 (dates subject to change depending on acquisition of approvals).\n* All participants must be fully consenting with a good understanding of what the study involves.\n\nExclusion Criteria:\n\n* Patients aged \\&lt;18 years.\n* Those that have not followed the pre-test preparation criteria, including: those that have not been sufficiently fasted prior to testing (6 hours for food, 3 hours for drinks); those that have not retained from taking proton pump inhibitor medication for 7 days prior to testing (lansoprazole, omeprazole, esomeprazole, rabeprazole, pantoprazole), histamine-2 receptor antagonist medication for 2 days prior to testing (famotidine, cimetidine, nizatidine), and other antacids on the day of testing (Gaviscon, Rennies, Peptac, etc).\n* Patients that lack the capacity to understand, retain, and communicate information to accurately complete questionnaires relating to their experienced symptoms.\n* Non-consenting patients.","ALL","18 Years","90 Years",{"count":42,"type":43},124,"ESTIMATED","OBSERVATIONAL","This research aims to investigate whether there is a link between irritable bowel syndrome (IBS) and acid reflux, particularly whether there is a difference in acid reflux symptoms between people with and without IBS.\n\nIBS is a functional gastrointestinal disorder, which has the same root cause as other functional gastrointestinal disorders that produce symptoms similar to acid reflux. Acid reflux symptoms may be typical (heartburn, regurgitation) or atypical (cough, sore throat, chest pain).\n\nAll participants are given two questionnaires: one to categorise them as either IBS or non-IBS, and one to understand their acid reflux symptoms. From this, the project will investigate whether there is a difference in the type (typical\u002Fatypical) and severity of acid reflux symptoms between people with and without IBS that attend for diagnostic acid reflux testing at Leeds Teaching Hospitals.\n\nTwo factors determine how much acid reflux someone has: the ability of the oesophagus (food- pipe) to move food from the throat to the stomach, and how well the muscle between the oesophagus and stomach works to keep acidic contents from moving back up.\n\nAll participants will have a test to see how well the muscles in their oesophagus are working. As there may be a link between IBS and oesophageal function, this project will investigate whether any patterns of abnormal oesophageal function can be identified in IBS patients that might explain their acid reflux symptoms.\n\nParticipants will then have a test that measures acid reflux over 24 hours, including the amount of acid and non-acid coming up, how high this reaches in the oesophagus, and whether symptoms are linked to these events.\n\nAnalysing these test results against questionnaire answers might help to understand the link between IBS and acid reflux to improve future diagnosis and treatment for the many people that have these conditions.",[47,48],"Irritable Bowel Syndrome","Gastro-oesophageal Reflux Disease","NOT_YET_RECRUITING","2024-09-24",{"date":52,"type":53},"2024-09-27","ACTUAL",{"date":55,"type":43},"2024-10-14",{"date":57,"type":43},"2025-05",{"name":5,"class":6}]