Real-World Analysis on the Diagnosis, Treatment Pattern and Outcomes for Patients With Gastro-Esophageal Reflux Disease (GERD) in China
Gastro-esophageal reflux disease (GERD), the most common cause of erosive esophagitis (EE), remains highly prevalent worldwide. GERD poses substantial burden on both patients and society. EE treatment patterns and unmet needs have been well-studied overseas, but evidence gaps still exist in China. To fill these evidence gaps, real-world evidence for GERD and EE are needed. To understand GERD market we will analysis :Patient profile,GERD patient journey within hospital (first present, get diagnosed, receive initial and maintenance treatment),medication cost,department differentiation. To investigate current treatment patterns of GERD / EE in China we will analysis: Current agents used and treatment duration in clinical practice treatment patterns by different reimbursement status treatment pattern by EE/NERD. To get healing rate of EE we will analysis: Real-world efficacy of the current standard treatment (i.e. PPIs) for patient with two test results of gastroscopy. The data required for this project are accessible in hospital electronic system; no specific data collection tools or methods are required for this project design. Only algorithms for retrieving and extracting eligible patients' records are required and will be developed by HLT based on the eligibility criteria defined in this protocol.
NCT03824548 — Gastro-esophageal Reflux Disease
Status: Recruiting
http://inclinicaltrials.com/gastro-esophageal-reflux-disease/NCT03824548/
A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-Group, Phase 3, Therapeutic Confirmatory Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 in Patients With Non-Erosive Gastroesophageal Reflux Disease
The purpose of this study is to demonstrate the superiority of efficacy of DWP14012, once daily (QD), compared to placebo in patients with non-erosive reflux disease at Week 4.
NCT03811080 — Non-Erosive Gastroesophageal Reflux Disease
Status: Recruiting
http://inclinicaltrials.com/non-erosive-gastroesophageal-reflux-disease/NCT03811080/
The Relationship Between Gastric Accommodation, Transient Lower Esophageal Sphincter Relaxations and Reflux Events in Healthy Subjects and in Gastro-esophageal Reflux Disease Patients With or Without Overlapping Dyspepsia
Our group recently studied the relationship between intra-gastric pressure (IGP) and reflux events after a meal, both in gastro-esophageal reflux disease (GERD) and in healthy volunteers (HV). Ingestion of a meal was accompanied by a drop in IGP, probably representing gastric accommodation (GA). However, the magnitude of this IGP drop varied, and was inversely correlated with the number of transient lower esophageal sphincter relaxations (TLESRs) and the number of reflux events, both in patients and in HV: a smaller meal-induced drop in IGP was associated with a higher rate of reflux events, and vice versa. These findings suggest that impaired GA is a trigger for reflux. Furthermore, impaired GA is a well-established mechanism underlying symptom generation in functional dyspepsia (FD). Hence, the investigators hypothesize that impaired GA is an important pathophysiological feature explaining the overlap between GERD and FD. To evaluate this hypothesis, the investigators will study the relationship between GA, TLESRs and reflux events in HV and in a group of GERD patients which will be categorized as pure GERD or GERD/FD overlap.
NCT03788109 — Functional Dyspepsia
Status: Completed
http://inclinicaltrials.com/functional-dyspepsia/NCT03788109/
The Relationship Between Acute Administration of a Bitter Compound and Transient Lower Esophageal Sphincter Relaxations and Reflux Events in Healthy Subjects
Recently the relationship between intragastric pressure (IGP) and reflux events after a meal was investigated, both in gastro-esophageal reflux disease (GERD) patients and in healthy volunteers. Ingestion of a meal was accompanied by a drop in IGP. However, the magnitude of this drop varied and was inversely correlated with the number of transient lower esophageal sphincter relaxations (TLESRs) and the number of reflux events, both in patients and in healthy volunteers: a smaller meal-induced drop in IGP was associated with a higher rate of reflux events and vice versa. This finding suggests that a smaller meal-induced drop may act as a trigger for reflux. It has been demonstrated that bitter administration leads to a smaller meal-induced drop. Therefore, bitter can be a dietary trigger for TLESRs facilitating the occurrence of symptoms of GERD. To evaluate this hypothesis, the researchers will study the relationship between bitter and the occurrence of TLESRs and reflux events in healthy volunteers. Additionally, it has been demonstrated that administering bitter also influences the concentration of motilin. Therefore, the research team will also measure the concentration of motilin to investigate whether changes in motilin concentrations can influence the number of TLESRs, via a change in gastric tone.
NCT03777787 — Gastro Esophageal Reflux
Status: Completed
http://inclinicaltrials.com/gastro-esophageal-reflux/NCT03777787/
Effect of Histamine-2 Receptor Antagonists on the Microbiome of Full Term Infants
The changes in the organisms making up the gut microbiota in infants who are taking anti-acid reflux medications (histamine 2 receptor antagonists) as compared to infants who are not taking these medications is not well-studied or understood. Whether these medications change the gut microbiota and microbiome, and what that change may imply for children on these medications, is the focus of this study.
NCT03747991 — GERD
Status: Completed
http://inclinicaltrials.com/gerd/NCT03747991/
Effect of Citalopram on Fasting and Postprandial Lower Esophageal Sphincter Function in Healthy Subjects: a Double-blind, Placebo-controlled, Randomized, Cross-over Study
Citalopram is sometimes used in the treatment for gastro-esophageal reflux disease, however, there are no empirical data to support this. The investigators would like to know if citalopram has an effect on the lower esophageal sphincter pressure, transient lower esophageal sphincter relaxations and reflux episodes. The investigators will investigate this by performing high resolution impedance manometry in healthy volunteers before and after a solid meal. This will be compared to placebo, in a cross-over, randomized, double-blind condition.
NCT03746691 — Gastro Esophageal Reflux
Status: Completed
http://inclinicaltrials.com/gastro-esophageal-reflux/NCT03746691/
Reflux in the Obese Undergoing Surgery or Endoscopy (ROSE) Previously: Gastroesophageal Reflux Disease (GERD) in Bariatric Patients
GERD is common in the obese population. Bariatric procedures are the mainstay of therapy for these patients. Bariatric procedures can be surgical (Roux-en-Y gastric bypass and Vertical sleeve gastrectomy) or endoscopic (endoscopic sleeve gastroplasty). The rate of GERD after either treatment is unknown as is the rate of silent reflux. The study primary objective is to assess the incidence rate of GERD in bariatric patients that undergo either therapy.
NCT03705416 — Obesity
Status: Active, not recruiting
http://inclinicaltrials.com/obesity/NCT03705416/
A Placebo-controlled Trial With Prucalopride for the Treatment of Typical Reflux Symptoms in Patients With Gastro-esophageal Reflux Disease With Incomplete Proton Pump Inhibitor Response
Up to date there is no placebo-controlled trial to investigate the effect of prucalopride in patients with proven refractory GERD. Therefore, to evaluate the efficacy of prucalopride on the improvement in symptom severity and reflux parameters, we will conduct a randomized, parallel, placebo-controlled, single-blind study. 60 patients with refractory GERD symptoms will receive either placebo or prucalopride (Resolor®) 2 mg for a period of 4 weeks. Symptom severity will be assessed by a validated reflux questionnaire (ReQuest) and reflux parameters (acid exposure time and number of reflux episodes) will be assessed by means of a 24 hour impedance-pH monitoring.
NCT03676374 — GERD
Status: Recruiting
http://inclinicaltrials.com/gerd/NCT03676374/
Clinical Application of MUSE System for Ultrasound-guided Endoscopic Fundoplication for Gastro-esophageal Reflux Disease Patients
This is a spontaneous, prospective, monocentric, observational, cohort study, with the aim of evaluating the effect of ultrasound-guided endoscopic fundoplication using the Medigus Ultrasonic Surgical Endostapler (MUSESystem; MediGus, Ltd. Israel) in patients with esophageal or extra-esophageal gastro-oesophageal reflux disease (GERD)-related symptoms. The end of the study will be at the end of the 6-year follow-up of the last patient enrolled. The study proposes the following objectives: - Primary objective: to evaluate the efficacy of endoscopic fundoplication with MUSE for the treatment of GERD, through clinical experience, in terms of: - effect on GERD-Health Related Quality of Life (HRQL) and Reflux Symptom Index (RSI) questionnaire scores - effect on the use and dosage of proton pump inhibitors (PPI) - feasibility and safety of the endoluminal fundoplication procedure - Secondary objective: to characterize the treated patient population (demographic and objective data) and to identify the successful predictors of the procedure. The study design includes the following phases: *Preliminary patient evaluation and verification of inclusion criteria through: Upper GI endoscopy Esophageal high-resolution manometry 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI - 6-month follow-up: Upper GI endoscopy Esophageal high-resolution manometry 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI - 12-months follow-up: Upper GI endoscopy 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI - Yearly clinical follow-up (up to 6 years): PPI use GERD-HRQL and RSI questionnaires scores OFF PPI
NCT03669874 — Gastro-esophageal Reflux
Status: Recruiting
http://inclinicaltrials.com/gastro-esophageal-reflux/NCT03669874/
Comparing the Gastroesophageal Reflux on Endotracheal Intubation or the I-gel- Second Generation Supraglottic Airway Device in the Pneumoperitoneum and Trendelenburg Surgical Setting
In the use of the second supraglottic airway device- i-gel in the laparoscopic pneumoperitoneum and Trendelenburg (LPT) surgical positioning, our data reported that the leak fraction in the i-gel group was higher than in the endotracheal tube group.1 These air leak may be gone into the GI tract and cause the gastric distension resulting in the increasing risk of aspiration. Few studies investigated whether the risk of occurrence of the gastroesophageal reflux (GER), the changes of the lower esophageal sphincter (LES) while the GER occurred, and the stomach fullness in the i-gel group than in the endotracheal tube group. We aim to observe the changes of gastroesophageal function parameters by esophageal manometry, pH impedance, and intra-abdominal pressure before and after laparoscopic pneumoperitoneum during anesthesia, all via the second SADs.
NCT03634449 — Gastroesophageal Reflux in Laparoscopy
Status: Recruiting
http://inclinicaltrials.com/gastroesophageal-reflux-in-laparoscopy/NCT03634449/