Clinical Research Directory

LINX vs Fundoplication

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.

The Effect of Probiotic and Zinc Supplementation in Patients With Gastroesophageal Reflux Disease

Introduction: Gastroesophageal 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). Background on Probiotics and Zinc: Probiotics 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). Zinc, 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. Study Aim: To evaluate the effect of probiotics and zinc on GERD symptoms and to explore their potential antioxidant and anti-inflammatory effects. Patients and Methods: Study Design: This is a prospective controlled randomized comparative study conducted at El-Demerdash Hospital, Ain Shams University Hospitals. Ethical Considerations: The 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. Participants: Inclusion Criteria: Adults aged 18-74 years with esophagitis confirmed by gastroscopy and GERD symptoms. Exclusion Criteria: Allergy to study medications, pregnancy, severe renal or liver insufficiency, history of myocardial infarction, stroke, malignant tumors, and certain gastrointestinal conditions or surgeries. Sample Size Calculation: The 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. Study Groups: Group I (Control): PPI (Omeprazole 40 mg daily). Group II: PPI + probiotic. Group III: PPI + zinc. Group IV: PPI + probiotic and zinc. Methodology: Participants 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. Outcomes: Primary Outcome: Change in Gastrointestinal Symptom Rating Scale (GSRS) scores and gastrin hormone levels before and after treatment. Secondary Outcomes: Anti-inflammatory effect (IL-6, IL-12, CRP levels). Antioxidant effect (MDA levels). Statistical Analysis: Data 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). This 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.

The Influence of Concomitant Irritable Bowel Syndrome on Gastro-Oesophageal Reflux Disease Symptoms and Severity.

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. IBS 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). All 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/atypical) and severity of acid reflux symptoms between people with and without IBS that attend for diagnostic acid reflux testing at Leeds Teaching Hospitals. Two 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. All 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. Participants 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. Analysing 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.

Osteopathic Manipulative Treatment for Gastro-oesophageal Reflux Disease

To evaluate the effects of osteopathic manipulative treatment in patients affected by symptoms related to gastro-oesophageal reflux disease (GERD)