Efficacy of Reza Band for the Treatment of Laryngopharyngeal Reflux
We hypothesize that tissue and salivary pepsin will resolve after 12 weeks use of Reza Band, but not following standard of care alone. Additionally, RFS, RSI and inflammatory cytokines (IL -1β, -6, and -8) will decrease to normative levels following 12 weeks use of Reza Band, but not with standard of care alone. Primary Objective The primary objective is to evaluate the efficacy of the Reza Band for the treatment of LPR. We propose a pilot clinical trial to test the hypothesis that the Reza Band is effective for the treatment of LPR, measured by resolution of pepsin and decrease to normative values for RSI, Reflux Finding Score (RFS) and inflammatory cytokines. The long-term goal is to determine the efficacy of the Reza Band in the sequential progression of reflux-attributed laryngeal inflammatory and neoplastic disease.
NCT03463395 — Laryngopharyngeal Reflux
Status: Withdrawn
http://inclinicaltrials.com/laryngopharyngeal-reflux/NCT03463395/
Treatment Response of Maintenance Dose of Proton Pump Inhibitor in Patients With Nonerosive Gatroesophageal Reflux Disease
For ERD(erosive reflux disease), which pathogenesis is mainly the acid reflux mechanism, primary treatment is therefore PPI. However, NERD(non-erosive reflux disease) is much more complex than ERD and there are more factors causing the typical symptoms. As a result, there is no consensus for the treatment of NERD besides using PPI similar to GERD(gastroesophageal reflux diseas). This study intent to evaluate the effect of PPI(Esomezol) on NERD patients and analyze the improvement of symptoms and the factors related to the result.
NCT03436914 — Non-erosive Gatroesophageal Reflux Disease
Status: Completed
http://inclinicaltrials.com/non-erosive-gatroesophageal-reflux-disease/NCT03436914/
A Randomized, Double Blind, Crossover Trial Comparing Fexofenadine to Placebo for the Treatment of Proton Pump Inhibitor Refractory Gastroesophageal Reflux Symptoms
The investigators wish to study the effectiveness of Fexofenadine (an over the counter allergy pill) for the treatment of gastroesophageal reflux symptoms in patients who still have symptoms despite being on a proton pump inhibitor. The investigators will do this by giving participants both Fexofenadine (an H1 blocker) for 2 weeks and placebo (sugar pill) for 2 weeks. The participants will not know which drug they are getting at a particular time. This will help the investigators better assess the true effectiveness of Fexofenadine.
NCT03425097 — Gastroesophageal Reflux
Status: Terminated
http://inclinicaltrials.com/gastroesophageal-reflux/NCT03425097/
The Role of Laryngopharyngeal Reflux in IPF
The primary objective of this study is to show that the Supraglottic Index (SGI) is an easily-collected index that accurately identifies the presence and severity of laryngopharyngeal reflux (LPF) in idiopathic pulmonary fibrosis (IPF).
NCT03418350 — Reflux
Status: Recruiting
http://inclinicaltrials.com/reflux/NCT03418350/
Correlations Between 96-Hour Wireless pH Monitoring and Variation in Reflux Disease Questionnaire, 7-day Recall
The diagnosis of gastro-oesophageal reflux disease (GORD) is often based on 24-hour catheter-based pH studies. The Bravo™ wireless pH monitoring revolutionised the study of GORD, allowing patients an improved comfort and ability to perform activities of daily living. The backflow of gastric acid (acid exposure) in the oesophagus is monitored by a tiny pH sensor located in a capsule which is pinned temporarily to the wall of the oesophagus at the time of endoscopy. Normal measurements (also called parameters) for acid exposure are established for 48-hour studies. However, our studies have shown that extending the duration of recording to 96 hours further improved the diagnostic yield for GORD in patients with negative 24-hour catheter-based tests. While pathologic acid exposure and symptom-reflux association in catheter-based pH studies anticipate a successful outcome after anti-reflux surgery, the clinical relevance of increasing the duration of recording is lacking. This study aims to investigate the relationship between the result of participants Bravo test and their symptoms on their usual medication. This is a single centre, prospective, observational study enrolling males and non-pregnant females over the age of 18 years with gastro-oesophageal symptoms in accordance with Montreal criteria and who have clinical indications for Bravo™. The study is based on questionnaires. All clinical interventions, including 96-hour Bravo™ pH monitoring, temporary cessation of medication and outpatient clinic follow-up is offered as routine medical care, regardless of their participation in the study. Patients will be contacted over the phone ten days before the procedure by a member of the research team involved in their clinical care and asked whether they would be interested in joining the study. Participants will complete a "baseline" 7-day recall Reflux Symptom Questionnaire (RESQ-7) before having Bravo™ for 96 hours. Participants will have a telephone follow-up at 4 weeks and 8 weeks to assess their symptoms based on the RESQ-7 questionnaire. We anticipate the recruitment of 100 subjects over 14 months. The final endpoints will be achieved 6 months after the last patient has been interviewed.
NCT03407456 — Gastroesophageal Reflux
Status: Completed
http://inclinicaltrials.com/gastroesophageal-reflux/NCT03407456/
Optimizing Patient Outcomes Through Early Detection of Uncontrolled Acid Reflux After Endoscopic Therapy in Barrett's Esophagus
This study is looking at a cohort of patients who have undergone treatment for Barrett's Esophagus (BE) and who have experienced complete eradication of the disease. The aim of the proposed study is to evaluate the histologic features of the neosquamous epithelium (NSE) following complete eradication of intestinal metaplasia (CE-IM) in patients undergoing routine surveillance biopsies and compare these data to a direct measure of reflux using 24hr pH impedance, to determine the correlation between histology and persistent reflux. These data will allow us to more accurately risk stratify patients for recurrence of BE following EET.
NCT03375060 — Barrett Esophagus
Status: Completed
http://inclinicaltrials.com/barrett-esophagus/NCT03375060/
A Superiority Study for Postoperative Reflux After Distal Gastrectomy With Antiperistaltic vs Isoperistaltic Billroth II + Braun Anastomosis
Postoperative gastroesophageal reflux is one of the most common complications of distal gastrectomy. With more attention paid on it by surgeons, several new operation methods have been practised. Among all these, distal gastrctomy with Billroth II + Braun anastomosis was reported to be an useful method to decrease postoperative reflux rate. Meanwhile, the direction of anastomotic peristalsis has also been reported to affect the anastomosis and thus make difference in reflux rate. We design this study to investigate the potential effect and the superiority of antiperistaltic vs isoperistaltic Billroth II + Braun reconstruction in distal gastrectomy.
NCT03372681 — Gastric Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/gastric-cancer/NCT03372681/
Efficacy and Safety of DLBS2411 Compared to Omeprazole in the Management of Gastroesophageal Reflux Disease (GERD)
This is a 2-arm, prospective, double-blind double-dummy, randomized-controlled study comparing DLBS2411 at a dose of 250 mg twice daily with omeprazole at a dose of 20 mg twice daily, given before morning and evening meals, for an 8-week course of therapy. Subjects should avoid taking meals 2-3 hours before bedtime. The bioactive fraction of DLBS2411 has been proved at cellular and genetic levels to have an antiulcer effect through both suppressing the gastric acidity and enhancing gastric mucosal protection. The anti-secretory effect of DLBS2411 is exerted through the inhibition of H+/K+ ATPase 'pump' as well as down-regulation of the H+/K+ ATPase gene expression, thus suppressing gastric acid secretion; while its cytoprotective defense mechanism works through the promotion of cyclooxygenase-2 (COX-2) derived prostaglandin (PgE2) synthesis, thus promoting gastrointestinal submucosal blood-flow, stimulating secretion of gastric-epithelial mucous and bicarbonate; anti-oxidative activity; and endothelial-nitric oxide (NO) formation. Recent study of DLBS2411 which was conducted in healthy volunteers, demonstrated the effective role and safety of DLBS2411 in suppressing intragastric acidity. Having such mechanisms of action, DLBS2411 is hypothesized to benefit patients with gastric acid disorders such as in gastroesophageal reflux disease (GERD).
NCT03367195 — Gastroesophageal Reflux Disease (GERD)
Status: Terminated
http://inclinicaltrials.com/gastroesophageal-reflux-disease-gerd/NCT03367195/
Monocentric Study Evaluating the Efficiency and Safety of Anti-reflux Mucosectomy ARMS for the Gastro-Esophageal reflux Disease
Currently patients with gastroesophageal reflux disease (GERD) are treated with proton pump inhibitors (PPIs). This long-term PPI treatment would likely increase the risk of pulmonary and digestive infections and would not prevent evolution to adenocarcinoma of Barrett's Esophagus. Surgical fundoplication is generally recommended when symptoms are poorly controlled with PPIs and considered as standard treatment despite celioscopy risk. A variety of endoscopic techniques for the treatment of GERD has been proposed to obtain non-surgical control. These endoscopic techniques aim to bring the tissues closer to the Œsogastric (JOG) junction. But a low response rate has been demonstrated with these techniques. H. Inoue (inventor of the anti-reflux mucosectomy 20 years ago) and his team postulated that the reflux symptoms would be reduced by creating a relative restriction of gastric cardia. The healing of the mucosectomy zone led to restriction of gastric cardia. This observation suggested that ARMS could represent an effective anti-reflux procedure with the advantage that no prostheses would be left in situ. Few studies have evaluated this new endoscopic technique. The purpose of this study is to evaluate the feasibility and safety of gastric mucosectomy for patients with GERD resistant to medical treatment or requiring long-term maintenance medical treatment.
NCT03357809 — GERD
Status: Suspended
http://inclinicaltrials.com/gerd/NCT03357809/
Prevalence and Clinical Characteristics of Patients With Jackhammer Esophagus and Symptoms of Gastroesophageal Reflux Disease
Gastroesophageal reflux disease (GERD) is involved in the development of esophageal motility disorders like Jackhammer esophagus (JE), a novel hypercontractile condition that was associated with progression to achalasia and limited outcomes following surgical anti-reflux therapy. This trial was designed to assess the prevalence and characteristics of JE in patients with typical symptoms of GERD and responsiveness to PPI therapy.
NCT03347903 — Esophageal Motility Disorders
Status: Completed
http://inclinicaltrials.com/esophageal-motility-disorders/NCT03347903/