[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastro-oesophageal-reflux-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastro-oesophageal-reflux-disease":126},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,82,104],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100602250","validation-of-a-parent-administered-symptom-score-for-unsettled-infants-every-baby-is-unique-100602250",false,"NCT07121062","Validation Of A Parent Administered Symptom Score For Unsettled Infants (Every Baby is UnIQue)","Validation Of A Parent Administered Symptom Score For Unsettled Infants","Inclusion Criteria:\n\n1. Consent to complete the anonymous questionnaire\n2. Parent 18 years old or over\n3. Parent of an infant aged under 12 months old at time of questionnaire completion\n\nExclusion Criteria:\n\n1. Parent does not consent to complete the anonymous questionnaire\n2. Parent under 18 years old\n3. Parent of an infant aged 12 months or older at time of questionnaire completion",true,"ALL","18 Years",{"count":20,"type":21},350,"ESTIMATED","OBSERVATIONAL","It's common for infants to be unsettled, especially in the first few months of life. While this is often normal, persistent symptoms can be stressful for families. Parents naturally seek explanations, and common suspected causes include colic, reflux, eczema, and cow's milk allergy (CMA). However, CMA is frequently over diagnosed, which can lead to unnecessary changes such as stopping breastfeeding or switching to expensive specialist formulas.\n\nTo address this, we've developed an online questionnaire to help track and understand symptoms in unsettled infants. Our long-term goal is to use this tool to support more accurate diagnosis of CMA. Before that, we need to test and validate the questionnaire in a general population of infants, including those who are healthy and those with other temporary conditions like a recent immunisation or teething.\n\nThis study involves an anonymous online survey for parents of babies under 12 months old. We aim to collect data from approximately 350 participants. The study will help us assess how well the questionnaire reflects the severity of symptoms and whether it can distinguish between healthy infants and those with underlying issues.\n\nParents will be invited to take part using flyers with a QR code distributed in various healthcare settings, including GP clinics and children's clinics in hospital. The survey is anonymous and hosted on a secure platform. While we don't anticipate the questions to be distressing, we recognise some may touch on sensitive topics. Support resources and study team contact details will be provided.\n\nBy validating this tool, we hope to improve how unsettled behaviour in infants is assessed-reducing unnecessary interventions and better supporting families and healthcare professionals.",[25,26,27,28,29,30],"Colic, Infantile","Milk Allergy, Cow's","Gastro Oesophageal Reflux Disease","Atopic Dermatitis (Eczema)","Constipation - Functional","Congential Hip Dysplasia",[32,33,34],"Infantile colic","Cows milk allergy","Unsettled behaviour","NOT_YET_RECRUITING","2025-08-06",{"date":38,"type":39},"2025-08-13","ACTUAL",{"date":41,"type":21},"2025-09",{"date":43,"type":21},"2026-08",{"name":45,"class":46},"University Hospital Southampton NHS Foundation Trust","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":81},"100600120","phase-3-linx-vs-fundoplication-100600120","NCT07093359","LINX vs Fundoplication","Double-blind Randomised Controlled Trial for Treatment of Gastro-Oesophageal Reflux Disease; LINX Management System vs. Fundoplication (GOLF)","GOLF","Inclusion Criteria:\n\n1. Age 18 years and above\n2. Willing and able to give informed consent\n3. Patients with GORD insufficiently controlled by medical therapy or intolerance to medical therapy being considered for anti-reflux surgery\n4. Symptomatic and objectively defined GORD; endoscopy with appearances or biopsies consistent with reflux oesophagitis, or 24-hour pH study or BRAVO test of the oesophagus consistent with GORD\n5. No hiatal hernia or hiatal hernia \\\u003C5 cm in length\n6. Adequate lower oesophageal motility as defined by preoperative oesophageal manometry study. Oesophageal manometry will show a mean contractile amplitude of \\>30 mmHg or DCI \\>450 mmHg-s-cm in 70% of swallows.\n\nExclusion Criteria:\n\n1. Unsuitable for surgical intervention due to medical conditions precluding general anaesthesia\n2. Suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials\n3. Previous anti-reflux or gastric surgery\n4. Previous or planned neurosurgical intervention\n5. Oesophageal manometry showing complete absence of lower oesophageal contractility",{"count":57,"type":21},460,"INTERVENTIONAL",[60],"PHASE3","Reflux disease can severely impact upon quality-of-life and lead to complications, including ulceration of the oesophagus. It is often controlled with self-help measures and medication. However, sometimes surgery is recommended. The current standard surgical treatment is called a fundoplication. This operation is carried out through keyhole (laparoscopic) surgery, and tightens the lower oesophagus to prevent reflux. Fundoplication is very safe and improves the quality-of-life of most patients. However, many patients have gas bloating, difficulty swallowing and recurrence of their reflux symptoms. As an alternative, some surgeons use a device called LINX, using a keyhole procedure. LINX is a magnetic device that wraps around the lower oesophagus to prevent reflux. Studies suggest that LINX may cause fewer complications, with a similar improvement in quality-of-life. However, there is a need for better evidence to compare LINX with fundoplication in the surgical treatment of reflux disease. GOLF is a multi-centre study designed which to determine if LINX achieves similar reflux control and improves symptoms compared to fundoplication. GOLF measures: (1) quality of life,(2) surgical complications, including need for additional treatment, (3) financial cost-effectiveness and (4) objectively measure the presence of acid that has refluxed into the lower oesophagus. GOLF aims randomise 460 patients to receive fundoplication or the LINX device. It will be conducted across at least 16 UK and 7 European specialist surgical centres. All participants will be followed up at 6 weeks, 6, 12 and 24 months to assess which treatment offers the best results after surgery. A quality assurance programme within participating centres will ensure that procedures are completed to a high-quality standard. Study results will incorporate a patient and public involvement programme, which will inform national and international guidelines for the surgical treatment of reflux disease.",[63],"Gastro-oesophageal Reflux Disease",[65,66,67,68,69,70],"LINX","GORD","GERD","Fundoplication","REFLUX","ANTI REFLUX","RECRUITING","2025-08-04",{"date":74,"type":39},"2025-08-05",{"date":76,"type":39},"2025-03-06",{"date":78,"type":21},"2029-07",{"name":80,"class":46},"University of Oxford",5,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":58,"phases":91,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":4},"100567117","phase-4-the-effect-of-probiotic-and-zinc-supplementation-in-patients-with-gastroesophageal-reflux-disease-100567117","NCT06664008","The Effect of Probiotic and Zinc Supplementation in Patients With Gastroesophageal Reflux Disease","Inclusion Criteria:\n\n* Adults aged 18-74 years; (both male and female).\n* Esophagitis that might be confirmed by gastroscopy.\n* Patients with confirmed symptoms of GERD N.B.: The typical clinical presentation of GERD is heartburn and regurgitation. Heartburn is defined as a retrosternal burning sensation or discomfort that may radiate into the neck and typically occurs after the ingestion of meals or when in a reclined position. Regurgitation is a retrograde migration of acidic gastric contents into the mouth or hypopharynx . GERD can also present with various other symptoms that include dysphagia, odynophagia, belching, epigastric pain, and nausea.\n\nExclusion Criteria:\n\n* Allergy or potential allergy to the study medications.\n* Pregnancy.\n* Patients with CrCl\\< 20 ml\u002Fmin or on dialysis.\n* Patients with myocardial infarction, stroke, or malignant tumour.\n* Patients with liver insufficiency (liver enzymes \\> 2\\*upper limit of normal)\n* Heart Failure or ECG (electrocardiogram) abnormalities\n* Gastroscopy that revealed any of the following diseases within the last 2 months: bleeding, esophageal and gastric varices, upper gastrointestinal malignant lesions.\n* A history of gastroesophageal or duodenal surgery.","74 Years",{"count":90,"type":21},120,[92],"PHASE4","Introduction:\n\nGastroesophageal reflux disease (GERD) is a common digestive disorder affecting the esophagus and gastro-duodenum, presenting symptoms such as acid reflux and heartburn. GERD\\'s incidence, symptoms, and prognosis are heavily influenced by diet and lifestyle factors. Current management of GERD involves lifestyle modifications (e.g., weight loss, dietary changes) and pharmacologic agents like proton pump inhibitors (PPIs), histamine-2-receptor blockers (H2 B), antacids, and medications that affect gastrointestinal motility (Kröner et al., 2021).\n\nBackground on Probiotics and Zinc:\n\nProbiotics are non-pathogenic microorganisms that, when administered in adequate amounts, offer several health benefits, including improvement in conditions associated with inflammation and gut health. Probiotics, often of the Lactobacillusand Bifidobacterium species, interact with gut microbiota, enhance barrier function, and modulate immune responses (Cheng \\& Ouwehand, 2020; Kröner et al., 2021). Probiotics have been linked to reduced levels of inflammatory mediators, such as cytokines, and are recognized for their anti-inflammatory and antioxidant properties (Sharifi-Rad et al., 2020; Wang et al., 2017).\n\nZinc, specifically Zinc L-carnosine, exhibits antioxidant, cytokine modulation, and membrane-stabilizing properties, acting as a mucosal cytoprotective and anti-inflammatory agent (Efthymakis \\& Neri, 2022). Previous studies suggest that the combination of probiotics and zinc may be beneficial for gut health, but there is limited data on their effects on GERD symptoms, inflammation, and oxidative stress.\n\nStudy Aim:\n\nTo evaluate the effect of probiotics and zinc on GERD symptoms and to explore their potential antioxidant and anti-inflammatory effects.\n\nPatients and Methods:\n\nStudy Design:\n\nThis is a prospective controlled randomized comparative study conducted at El-Demerdash Hospital, Ain Shams University Hospitals.\n\nEthical Considerations:\n\nThe study has received ethical approval from the Research Ethics Committee of the Faculty of Pharmacy, Ain Shams University, and the Scientific Research Ethics Committee at the Faculty of Medicine, Ain Shams University. It adheres to the Declaration of Helsinki and is registered on ClinicalTrials.gov.\n\nParticipants:\n\nInclusion Criteria: Adults aged 18-74 years with esophagitis confirmed by gastroscopy and GERD symptoms.\n\nExclusion Criteria: Allergy to study medications, pregnancy, severe renal or liver insufficiency, history of myocardial infarction, stroke, malignant tumors, and certain gastrointestinal conditions or surgeries.\n\nSample Size Calculation:\n\nThe study is designed to detect a large effect size (f = 0.4) for zinc and probiotic effects using G\\*Power software. A total of 120 patients will be recruited (30 per group) to account for a 15% dropout rate.\n\nStudy Groups:\n\nGroup I (Control): PPI (Omeprazole 40 mg daily). Group II: PPI + probiotic. Group III: PPI + zinc. Group IV: PPI + probiotic and zinc.\n\nMethodology:\n\nParticipants will undergo baseline assessments, including medical history, gastroscopy, and measurement of gastrointestinal hormones, inflammatory markers (IL-6, IL-12, CRP), and oxidative stress markers (MDA). The same assessments will be repeated at the study\\'s end after 4 weeks. Follow-up assessments will occur biweekly, and patients will be contacted between visits to monitor side effects.\n\nOutcomes:\n\nPrimary Outcome: Change in Gastrointestinal Symptom Rating Scale (GSRS) scores and gastrin hormone levels before and after treatment.\n\nSecondary Outcomes:\n\nAnti-inflammatory effect (IL-6, IL-12, CRP levels). Antioxidant effect (MDA levels).\n\nStatistical Analysis:\n\nData will be analyzed using SPSS. Statistical significance is set at p ≤ 0.05. Continuous variables will be expressed as mean ± SD or median (interquartile range), depending on distribution, and analyzed using appropriate tests (e.g., T-test or Mann-Whitney U test).\n\nThis study aims to provide insights into the potential benefits of probiotics and zinc in managing GERD symptoms and their anti-inflammatory and antioxidant effects, filling a current gap in the literature.",[63],"2024-10-27",{"date":97,"type":39},"2024-10-29",{"date":99,"type":21},"2024-11-01",{"date":101,"type":21},"2025-10-01",{"name":103,"class":46},"Ain Shams University",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":4},"100563414","the-influence-of-concomitant-irritable-bowel-syndrome-on-gastro-oesophageal-reflux-disease-symptoms-and-severity-100563414","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 \\<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.","90 Years",{"count":113,"type":21},124,"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.",[116,63],"Irritable Bowel Syndrome","2024-09-24",{"date":119,"type":39},"2024-09-27",{"date":121,"type":21},"2024-10-14",{"date":123,"type":21},"2025-05",{"name":125,"class":46},"The Leeds Teaching Hospitals NHS Trust","Gastro-Oesophageal Reflux Disease"]