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Gastroesophageal Reflux clinical trials

View clinical trials related to Gastroesophageal Reflux.

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NCT ID: NCT06170060 Active, not recruiting - Hiatal Hernia Clinical Trials

Treatment of Reflux With Sleeve Gastrectomy

Start date: September 25, 2023
Phase: N/A
Study type: Interventional

In 2008, the World Health Organization (WHO) report found that 0.5-1.5 billion people aged 20 years and above suffer from overweight (body mass index (BMI) ≥ 25) and obesity (BMI ≥ 30 kg / m2) stated. WHO estimates that the number of overweight and obese people will reach 2.3 and 0.7 billion, respectively, by 2045. Bariatric surgery has been developed in response to the number of obese patients living in the world and the complications caused by obesity. The most common type of bariatric surgery against obesity is Laparoscopic Sleeve Gastrectomy (LSG). As after any surgical operation, complications may occur after Laparoscopic Sleeve Gastrectomy. Additional operations may be required to correct complications such as bleeding, anastomotic leak, gastric volvulus, infection, dyspepsia, hiatal hernia, bile and/or acid reflux. The incidence of gastroesophageal reflux disease (GERD) is significantly increased in obese patients compared to the incidence in normal individuals. Various studies have shown that obesity causes delayed gastric emptying due to increased abdominal pressure, esophageal motility disorders, especially hypotensive lower esophageal sphincter pressure (<10 mm Hg), finally the development of hiatal hernia (HH), whose prevalence in the obese population is significantly higher than in non-obese patients. Various surgical methods have been presented to prevent postoperative de-novo Gastroesophageal Reflux and de-novo Hiatal Hernia that occur after LSG. Curorrhaphy is one of these techniques that is accepted to prevent the formation or exacerbation of postoperative GERD and Hiatal Hernia. In this surgical technique, after the diaphragmatic crura are completely exposed at the level of the lower esophageal sphincter (LES), the hiatal hernia, if present, is reduced into the abdomen. Afterwards, Z surgical sutures are applied to the diaphragmatic crura to make the diaphragmatic esophageal ring narrow enough. In this way, it is aimed to strengthen the diaphragmatic crus. Findings following cruroplasty for GERD prevention are varied. Although some authors state that the technique does not provide an advantage in preventing postoperative GERD, some studies have shown cruroplasty to be effective. In this study, investigators aimed to show that the technique of simultaneous cruroplasty and single suture omentopexy with LSG is a treatment for GERD and HH, which are very common in obese patients, and a preventive technique for de-novo GERD seen after LSG.

NCT ID: NCT05689918 Active, not recruiting - Clinical trials for Gastro Esophageal Reflux

Gastroesophageal Reflux Disease in the Dutch Population

REFLUX
Start date: December 7, 2022
Phase:
Study type: Observational [Patient Registry]

Rationale: Screening for esophageal adenocarcinoma (EAC) precursors and treating them may help to decrease mortality of this malignancy. To understand the size of the target population for potential EAC screening, insight in the prevalence of registered and unregistered individuals with gastro-esophageal reflux disease (GERD) symptoms is needed. Insight in public awareness of EAC will provide additional useful information for public communication strategies. Objective: The aims of this study are to assess the prevalence of GERD symptoms and related help-seeking behavior, registered and unregistered medication use and awareness of esophageal cancer in the general Dutch population. Study design: Cross-sectional population-based survey. Study population: Dutch citizens aged 18-75 years. Methods: Eligible individuals will be selected from the Dutch population registry (BRP) using simple random sampling. Invitations will be sent by postal mail with participants being directed to a digital survey. Main study parameters/endpoints: The outcome variables are presence of current GERD symptoms, number of GERD patients that consulted a doctor, number of GERD patients using prescribed and/or over the counter (OTC) antacids, histamine-receptor antagonists (H2RAs) and proton pump inhibitors (PPIs), and awareness and beliefs about esophageal cancer. The association between socio-demographic background and outcome variables will also be evaluated. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects will not directly benefit from participating in this study. Nonetheless, participating in this study is not associated with any healthcare risks and the burden for the subjects is very low. The survey has a low burdensome nature and will take approximately 20 minutes to complete. All data will be pseudonymized, refusal to fill out the survey or desire to withdraw from the study will not have any consequences for the invited subject.

NCT ID: NCT05587322 Active, not recruiting - Clinical trials for Non-erosive Reflux Disease

A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Non-Erosive Reflux Disease

Start date: September 6, 2022
Phase: Phase 3
Study type: Interventional

The objective of the Treatment Phase of the study is to evaluate the safety and efficacy of 4 weeks of once daily oral administration of BLI5100 low dose, BLI5100 high dose, or placebo in patients with NERD. The objective of the Extension Phase of the study is to evaluate the safety of extended exposure to once daily oral administration of BLI5100 low dose and BLI5100 high dose in patients with NERD.

NCT ID: NCT05371717 Active, not recruiting - Clinical trials for Gastro Esophageal Reflux

Domiciliary Management of Dental Erosion in Patients With GERD With Biomimetic Hydroxyapatite

Start date: May 1, 2022
Phase: N/A
Study type: Interventional

The aim of the present study is to evaluate dental erosion in patients with gastroesophageal reflux disease (GERD). Patients consenting to participate to the study will undergo periodontal evaluation at the baseline. Then, professional dental hygiene will be performed. Patients will be randomly assigned to: - Trial group: home oral hygiene with Biorepair Total Protection + Biorepair Shock Treatment twice a day - Control group: home oral hygiene with Biorepair Total Protection Patients will be evaluated after 1, 3 and 6 months from baseline.

NCT ID: NCT05365087 Active, not recruiting - Clinical trials for Gastroesophageal Reflux Disease

Transoral Fundoplication Prior to Sleeve Gastrectomy Versus RNY Gastric Bypass on GERD Symptoms in Bariatric Patients

Start date: March 1, 2018
Phase:
Study type: Observational

A retrospective and prospective cohort study to compare the effect of completing a Transoral Fundoplication (TF) procedure prior to Laparoscopic Sleeve Gastrectomy (LSG) surgery to Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) in bariatric patients with Gastroesophageal Reflux Disease (GERD) signs and symptoms. The aim of this study is to examine the effect of TF prior to sleeve gastrectomy as compared to Roux-en-Y Gastric Bypass on reflux symptoms in bariatric patients. Additional Follow up data until 10 years will be collected to evaluate for sequelae of GERD.

NCT ID: NCT05363553 Active, not recruiting - Infant Development Clinical Trials

Transition to Infant Formula Feeding on Gastrointestinal Regurgitation (TIGER) Study

TIGER
Start date: May 25, 2022
Phase: N/A
Study type: Interventional

To compare the frequency of regurgitation and other digestive outcomes between infants who receive an infant formula based on whole goat milk and an infant formula based on cow milk proteins during the transition period from breastfeeding to formula feeding, using predominantly breastfed infants as a reference group.

NCT ID: NCT05283447 Active, not recruiting - Clinical trials for Gastroesophageal Reflux

Manual Therapy and Gastroesophageal Reflux Disease in Patients With Hiatal Hernia

Start date: November 15, 2018
Phase: N/A
Study type: Interventional

Introduction: Gastroesophageal reflux disease (GERD) is highly prevalent in our society. The association between GERD and hiatal hernia has been shown to be etiologically critical in the onset or worsening of these patients' clinic. Pharmacological treatment with proton pump inhibitors (IBPs) and H2 blockers is commonly prescribed and will be followed for many patients for life. The cost of health care and the effects of prolonged consumption of PPIs are questionable, and other therapeutic alternatives are being considered. Only in exceptional cases and in patients with GERD and certain types of hiatal hernia is surgery the treatment of choice. Physiotherapy at the time proposed respiratory and diaphragmatic training as a therapeutic alternative that would improve the function of anti-reflux barriers. Recently, other studies evaluating the effectiveness of manual techniques on the crural diaphragm or osteopathic maneuvers on the cervical and thoracic region have obtained good results in the improvement of the MRGE clinic. In this context, the clinical trial presented specifically treats those with reflux disease associated with a Type I hiatal hernia with manual therapy. Material and methods: The aim of the clinical study is to evaluate the effects of a clinical intervention protocol on patients with GERD for type I hiatal hernia. The variables are assessed: GERD impact using the GIS MRG Impact Scale, and the EVA format scale for the Reflux Clinic (IEPT) used by the Surgery Service of the Parc Taulí Hospital in Sabadell . The productivity and quality of life of these patients is also assessed using the QOLRAD reflux and dyspepsia patient quality of life questionnaire. The randomized, double-blind clinical trial has a sample of 44 patients, divided into an intervention group treated with the protocol under study, and a control group undergoing treatment that does not affect the hernia. hiatus and reflux. A total of three treatment sessions are performed on each subject. The participants answer the different questionnaires, before the start of the treatment and for each session, one week after the treatment and one month later. In the protocol, maneuvers are performed on the epigastric region, thoracic diaphragm, mediastinum and anterior face of the neck.

NCT ID: NCT04711655 Active, not recruiting - Clinical trials for Gastroesophageal Reflux Disease

Antireflux Ablation of the Cardia Mucosa vs Placebo for the Treatment of Gastroesophageal Reflux Disease

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

Gastroesophageal reflux disease (GERD) is defined as the presence of symptoms or complications secondary to the passage of gastric contents into the esophagus, oral cavity or structures of the airway. The prevalence worldwide is between 8-33%. The clinical practice guidelines of the American College of Gastroenterology establish that first-line treatment, in the absence of alarm symptoms, should be carried out empirically. This treatment consists of hygienic-dietary measures and the use of proton pump inhibitors (PPIs) for 8-12 weeks. Despite the proven effectiveness of PPIs, there is 10-40% of patients who do not respond adequately to this treatment. All this has motivated the appearance of endoscopic and surgical techniques that offer an alternative to medical treatment. Among them is the technique of antireflux ablation of the cardiac mucosa (ARMA) in which the resection of the mucosa is replaced by an ablation with electrocoagulation current or by argon gas fulguration.

NCT ID: NCT04614974 Active, not recruiting - Clinical trials for Gastro Esophageal Reflux

Initiation of Acid Suppression Therapy Prospective Outcomes for Laryngomalacia

Start date: November 18, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Laryngomalacia (LM) is the most common cause of stridor in infants. Symptoms of gastroesophageal reflux (GER) are often seen in the setting of LM; therefore, acid suppression therapy (AST) has been empirically used in the management of this disorder. The investigators recently performed a retrospective chart review assessing improvement of airway and dysphagia symptoms, weight gain, and need for surgery with AST. It was found that there was a similar improvement between LM severity groups and most patients received AST (96.6%). It is unclear if these improvements are due to AST or natural resolution of the disease. With heightened concerns of side effects related to AST in infants, particularly among those born prematurely, judicious use of these medications is needed. The investigators are now performing a prospective study looking at the outcome differences in patients with laryngomalacia who are evaluated by speech language therapy (SLP) alone versus those with SLP evaluation and acid suppression therapy (famotidine).

NCT ID: NCT04500288 Active, not recruiting - Clinical trials for Gastro Esophageal Reflux

The Effect of Positional Therapy on Symptoms of Gastroesophageal Reflux Disease: A Prospective Pilot Study

Start date: March 4, 2021
Phase: N/A
Study type: Interventional

Gastroesophageal reflux disease related symptoms are reported by 10-20% of the adult population and of those 50-75% report symptoms during sleep time. The prevalence of nocturnal GERD (nGERD) is estimated to be about 25% in general population. nGERD causes sleep fragmentation, difficulty falling asleep, daytime sleepiness, reduced work productivity and decreased quality of life. Additionally, nighttime gastroesophageal reflux has been associated with increased risk of GERD-related complications such as severe erosive esophagitis, peptic stricture, esophageal ulcer, Barrett's esophagus, and esophageal adenocarcinoma. Furthermore, nocturnal gastroesophageal reflux has been noted to be associated with atypical and extra-esophageal manifestations as well as sleep disturbances. Overall, patients with nocturnal gastroesophageal reflux are more likely to develop a more severe form of GERD. The mainstay of treatment of nighttime gastroesophageal reflux is a proton pump inhibitor (PPI). However, nighttime heartburn is the most common breakthrough symptom in patients with GERD, who failed PPI treatment. Other important therapies for nighttime GERD include, lifestyle modifications, such as elevating the head of the bed, avoiding eating at least three hours before bedtime, maintaining appropriate sleep hygiene and avoiding the right decubitus position. Elevating the upper torso by raising the head of the bed and avoiding the right-lateral decubitus position have been shown to improve nocturnal symptoms. Several studies have shown that sleeping in the left decubitus position decrease esophageal acid exposure by reducing 13-76% of the reflux episodes. Studies have shown that the right decubitus position increases the rate of transient lower esophageal sphincter relaxations (TLESRs) accompanied by acid reflux, as compared with the left recumbent position. Moreover, maintaining the left lateral recumbent position, reduced by 87% esophageal acid exposure and nocturnal symptoms. LEFT is a novel electronic wearable device that was developed as a sleep position therapy for patients who suffer from nighttime gastroesophageal reflux symptoms. It is simple, noninvasive and low-cost technology which has been developed by Side Sleep Technologies B.V. Singel, Amesterdam, The Netherland. This technology is designed to train patients to sleep on their left side by a gentle vibration signal once it detects that they are sleeping on their back or right side. Thus, this technique may reduce gastroesophageal reflux and thus provides relief of heartburn and regurgitation during sleep time. The purpose of this study is to determine the usefulness of positional therapy, using the LEFT device, as a nonmedical tool to control GERD-related nocturnal symptoms.