A Randomized Trial of Thickened Feeds to Treat Gastroesophageal Reflux in Children Admitted to Boston Children's Hospital After Brief Resolved Unexplained Event
Infants often present to the hospital with episodes of coughing, choking, gagging, change in muscle tone, and/or change in skin color, known as brief resolved unexplained event. Many studies have tried to address why infants have these symptoms and if there is a way to prevent them from happening again. Currently, there is no clear agreement on the most common cause of these symptoms or how to prevent them. Some studies have suggested that gastroesophageal reflux can cause these symptoms. The investigators are conducting a study of infants who are admitted to Boston Children's Hospital with episodes of coughing, choking, gagging, change in muscle tone, and/or change in skin color, symptoms that could be reflux. The investigators want to determine if these symptoms can be prevented by changing the way infants are fed, either by giving them a formula to treat reflux or by thickening their feeds to treat reflux. The goal of the study is to determine if different types of feeding interventions prevent infants from coming back to the hospital.
NCT03130543 — Gastroesophageal Reflux
Status: Terminated
http://inclinicaltrials.com/gastroesophageal-reflux/NCT03130543/
Vonoprazan Study of Investigating the Effect on Sleep Disturbance Associated With Reflux Esophagitis- Exploratory Evaluation (VISTAEXE)
The purpose of this study is to exploratorily evaluate the effect of vonoprazan 20 mg on sleep disturbance of patients with reflux esophagitis, who have heartburn and/or regurgitation and ≥ 6.0 in the Pittsburgh Sleep Quality Index (PSQI) global score despite the maintenance treatment with PPI other than vonoprazan.
NCT03116841 — Reflux Esophagitis
Status: Completed
http://inclinicaltrials.com/reflux-esophagitis/NCT03116841/
Prospective, Randomized, Controlled Trial of Omega Loop Gastric Bypass With and Without Anti-reflux Sutures - a Pilot Study
This proposed trial is designed to answer the following questions: First, is biliary reflux to the distal esophagus present before OLGB and does it increase after the procedure? Second, does performing an OLGB with or without anti-reflux sutures make a difference in (biliary) reflux exposures of the distal esophagus? To answer these questions the investigators plan to perform a randomized, controlled trial involving two groups. Group A will undergo an OLGB without anti-reflux sutures and consists of 50 patients. Group B will receive an OLGB with anti-reflux sutures and also consists of 50 patients. Gastroscopic evaluation for inflammation and reflux will be performed before and one year after the operation utilizing multilevel intraluminal impedance pH-monitoring (MII-pH) and intragastric Bilitec 2000™. Furthermore, the study will be blinded to the patient. Long-term weight loss, the resolution of comorbidities and the incidence of surgical complications will serve as secondary endpoints. Follow-ups will be performed at 3, 6, and 12 months postoperatively to assess all primary and secondary goals.
NCT03097887 — Bile Reflux
Status: Recruiting
http://inclinicaltrials.com/bile-reflux/NCT03097887/
A 12-month Double-blind, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Efficacy of Endoluminal Aluvra™ for the Treatment of Gastroesophageal Reflux Disease
This is a prospective, multi-center, double-blind, crossover, randomized controlled trial designed to demonstrate the safety and efficacy of Aluvra for the treatment of GERD.
NCT03090607 — GERD
Status: Active, not recruiting
http://inclinicaltrials.com/gerd/NCT03090607/
Omeprazole 20 mg in Patients With Laryngopharyngeal reflux and Comorbid Chronic Rhinosinusitis - a Randomized, Double Blind, Placebo Controlled Trial
The hypothesis of this study is that a gastroesophageal reflux recommended treatment with proton pump inhibitor (dose and duration) compared to placebo significantly reduces both the signs and symptoms of laryngopharyngeal reflux and comorbid chronic rhinosinusitis. Primary objective was to determine whether 8 weeks of treatment with omeprazole 20 mg ones daily (OD) significantly reduces the signs and symptoms of laryngopharyngeal reflux when compared to placebo in patients with laryngopharyngeal reflux with comorbid chronic rhinosinusitis. Secondary objectives were to determine whether 8 weeks of treatment with omeprazole 20 mg OD significantly reduces the signs and symptoms of comorbid chronic rhinosinusitis in patients with laryngopharyngeal reflux when compared to matching placebo; and to investigate the association of the severity of signs and symptoms of laryngopharyngeal reflux with the ones of chronic rhinosinusitis in the same group of patients. The research was carried out as a double blind randomized placebo controlled trial. Patients were randomized into two groups in an approximate 1:1 ratio using a concealed random sequence. After randomization and initial assessment treatment was initialized. Patients on active treatment were given omeprazole 20 mg once daily half an hour before breakfast for 8 weeks, while those in the placebo group were given matching placebo tablets using the same regimen for 8 weeks as the group on the active treatment. Patients were reassessed at the end of treatment for signs and symptoms of laryngopharyngeal reflux and comorbid chronic rhinosinusitis.
NCT03086070 — Chronic Rhinosinusitis (Diagnosis)
Status: Completed
http://inclinicaltrials.com/chronic-rhinosinusitis-diagnosis/NCT03086070/
Study of Gastro-oesophageal Reflux in Patients Having Had Bariatric Surgery
Obesity surgery has become commonplace nowadays. This type of surgery is in full swing and although it is mostly beneficial for the health of the patient (reduction of cardiovascular risks, improvement of self image, reduction of osteo-articular risks, etc...) it is however associated with risks. There are several short and long term complications, excluding the ones related to the anesthesia and the post-op recovery: fistulas, abcesses, infections, dysphagia, risks of endobrachyoesophagus, etc... The gastroœsophageal reflux remains by far the most common post-op complaint within patients. Patients can experience symptoms as far as 3 years after the surgery. Medical treatment alone can in most cases lighten the symptoms. However, in some cases, this treatment fails and another type of surgery (bypass) must be undertaken, which is psychologically traumatic for the patient. This retrospective study will analyze a cohort of patients who underwent bariatric surgery (mainly sleeve gastrectomy), in order to identify those at risk of developping gastroœsophageal reflux and how this complication can be avoided in pre-op. The study will also identify cases of invalidating gastroœsophageal reflux that can be solved by obesity surgery.
NCT03077906 — Gastroesophageal Reflux
Status: Completed
http://inclinicaltrials.com/gastroesophageal-reflux/NCT03077906/
A Study on the Diagnosis of Minimal Change Esophagitis in Nonerosive Reflux Esophagitis and Gastroesophageal Reflux Disease Using Linked Color Imaging
Linked color imaging(LCI),a new system for endoscopy modality,creates clear and bright endoscopic images by using short-wavelength narrow-band laser light combined with white laser light on the basis of magnifying blue laser imaging(BLI) technology.LCI makes red areas appear redder and white areas appear whiter.Thus,it is easier to recognize a slight difference in color of the mucosa.This is a study to assess the effectiveness of LCI for diagnosing esophageal minimal endoscopic lesions and Los Angeles classification system when compared to conventional white-light endoscopy (WLI).Gastroesophageal reflux disease(GERD) is a common disease that be defined as a condition which develops when the reflux of stomach contents cause troublesome symptoms and/or complications.Esophageal injury was classified according to the Los Angeles classification system,Non-erosive reflux disease(NERD) is defined by the presence of troublesome reflux-associated symptoms and the absence of mucosal breaks at endoscopy,which includes minimal change oesophagitis and no endoscopic abnormalities.LCI improved the visualization of the squamocolumnar junction (SCJ) by enhancing the contrast,mucosa minimal changes could be seen more easily and clearly with LCI than with standard white-light endoscopy.By comparing White-light endoscopy and LCI,it will show if there is any comparable advantage to using one or the other for lesion detection.
NCT03068572 — Gastroesophageal Reflux Disease
Status: Recruiting
http://inclinicaltrials.com/gastroesophageal-reflux-disease/NCT03068572/
Association Between Cardiorespiratory and Gastroesophageal Reflux Events in Infants.
Cardiorespiratory and gastroesophageal reflux events often coexist in infants in Neonatal Intensive Care Unit (NICU) thus leading to drugs over-prescription and delayed discharge. Through cardiorespiratory and pH-impedance monitoring this study aims to evaluate the temporal association between gastroesophageal reflux (GER) and cardiorespiratory (CR) events in a large number of infants with gastroesophageal reflux disease (GERD) and CR symptoms and, whether this association is significant, to clarify the impact of GER on CR events.
NCT03053609 — Gastroesophageal Reflux Disease
Status: Completed
http://inclinicaltrials.com/gastroesophageal-reflux-disease/NCT03053609/
Genotype-tailored Treatment of Symptomatic Acid-Reflux in Children With Uncontrolled Asthma
This study will evaluate the effect of CYP2C19 and ABCB1 genes on pharmacokinetics of lansoprazole in children with mild gastroesophageal reflux (GER) and uncontrolled asthma. It will determine if genotype-guided lansoprazole dosing of lansoprazole improves GER and asthma control.
NCT03015610 — Asthma
Status: Completed
http://inclinicaltrials.com/asthma/NCT03015610/
Gastroesophageal Reflux Poses a Potential Risk for Late Complications of BPD: A Prospective Study
Bronchopulmonary dysplasia (BPD) is a common condition in the low birth weight infants. Although most of the BPD symptoms improved after a regular treatment in infancy, there are still a few late complications left such as the frequent respiratory symptoms, a slower weight gain and even sudden death. These late complications have made so much trouble to the healthcare of BPD infants. How to find the risk factors and to reduce the prevalence of these late symptoms becomes necessary. In this study, a cohort of BPD infants was observed with the late complications obtained by a monthly followed up for 18 months after discharge, the prevalence and risk factors of the late complications of BPD were analyzed by logistic regression. As one of the risk factors, GER was verified whether to play a critical role in these late complications.
NCT03014453 — Bronchopulmonary Dysplasia
Status: Completed
http://inclinicaltrials.com/bronchopulmonary-dysplasia/NCT03014453/