Clinical Trials Logo

Gastroesophageal Reflux clinical trials

View clinical trials related to Gastroesophageal Reflux.

Filter by:

NCT ID: NCT05080634 Recruiting - GERD Clinical Trials

Analysis of Prevalence and Risk Factors Associated With Gastroesophageal Reflux Disease and Esophagitis After Peroral Endoscopic Myotomy

Start date: June 1, 2021
Phase:
Study type: Observational [Patient Registry]

Achalasia is an uncommon disorder that results from the degeneration of ganglion cells of the myenteric plexus in the lower esophageal wall. Peroral endoscopic myotomy (POEM) is a minimally invasive procedure capable of overcoming limitations of achalasia treatments. This study aimed to: 1) identify the prevalence of reflux esophagitis and asymptomatic GERD in patients who underwent POEM, and 2) evaluate patient and intraprocedural variables associated with post-POEM GERD.

NCT ID: NCT05068089 Not yet recruiting - Clinical trials for Gastro-Esophageal Reflux

Health, Economic Analysis and Clinical Aspects of Patients With Neurological Disabilities in Enteral Nutrition With Dedicated Formula. The Role of Nissen's Fundoplication in the Management of Gastroesophageal Reflux

Start date: November 1, 2021
Phase:
Study type: Observational

Nutritional difficulties are common in children with neurodisabilities and can be associated with malnutrition and gastrointestinal diseases, such as gastro-esophageal reflux disease (GERD) and constipation. Neurological disorders can be divided into two main categories: progressive (neurodegenerative, mitochondrial disease) and non-progressive (cerebral palsy) neurodisabilities; nature of the disorders can impair on the nutritional status of these children. In 2017, ESGHAN published guidelines with specific nutritional claims. Approximately 46%-90% of children with neurodisabilities suffer from malnutrition and an enteral feeding is necessary to reach the nutritional requirements. In addition, a relevant issue for these children is GERD, reaching up to 70% prevalence. The treatment of GERD could be based on pharmacological therapy (protonic pomp inhibitor, PPI), on nutritional treatment (changing type of formula) or on surgical treatment (Nissen Fundoplication). European guidelines for GERD recommend PPI as the first line, with fundoplication being considered in cases of failure of optimized medical therapy. Enteral feeding can be considered in order to avoid malnutrition and is justified when other efforts to increase nutritional intake. Enteral feeding can be provided by nasal tube at the beginning, but a gastrostomy feeding tube would be preferred for a long-term nutrition (greater than six weeks). A jejunal tube can be introduced through the gastrostomy; jejunal feeding is appropriate in patients with recurrent vomiting and/or tube feeding-related aspiration, severe gastroesophageal reflux, and gastroparesis. Different types of formulas can be used for enteral nutrition and can be offered by nasal tube, percutaneous endoscopic gastrostomy (PEG) or percutaneous endoscopic jejunostomy (PEJ). Whey-based formulas have been shown to empty from the stomach more rapidly than casein-based formulas, which may be helpful for patients presenting with delayed gastric emptying. Use of peptide-based, 100% whey protein formulas are associated with improved feeding tolerance, increased consistency in meeting nutritional needs, and a reduction in gastrointestinal issues associated with vomiting and aspiration of feeds. For these reasons, the aim of this study is to retrospectively evaluate the role of different formulas against Nissen fundoplication, regarding tolerance, utility, applicability and safeness of these products, by performing a cost analysis.

NCT ID: NCT05066594 Recruiting - Clinical trials for Gastro Esophageal Reflux

Observational Registry of Transoral Incisionless Fundoplication (TIF) for Gastroesophageal Reflux Disease (GERD)

TIF/2021
Start date: May 1, 2021
Phase:
Study type: Observational [Patient Registry]

This observational registry aims to: 1) record the TIF interventions in patients with esophageal or extra-esophageal symptoms; 2) to monitor the therapy response through the clinical experience in terms of effect on the use and dosage of proton pump inhibitors (PPIs) and on the GERD-Health Related Quality of Life (HRQL) and Reflux Symptom Index (RSI) questionnaires scores; 3) to characterize the treated patients population and the predictive factors of TIF success, identifying the subpopulation who may effectively benefit from TIF.

NCT ID: NCT05062876 Completed - Clinical trials for Gastroesophageal Reflux Disease

A Study to Compare PK, PD and Safety of the AD-214 and AD-2141

Start date: November 1, 2021
Phase: Phase 1
Study type: Interventional

A study to compare safety, pharmacokinetics and pharmacodynamics of AD-214 to AD-2141 in healthy volunteers.

NCT ID: NCT05060744 Recruiting - Gastric Reflux Clinical Trials

Efficacy and Speed of Action of a Product to Control Gastric Hydration and Gastroesophageal Reflux

AQUAA
Start date: September 9, 2021
Phase: N/A
Study type: Interventional

A Randomised, Placebo-Controlled Clinical Trial off the Efficacy and Rapidity of Action of a Product Containing Sodium Alginate, Calcium and Magnesium Salts, Hyaluronic Acid and Aloe Vera to Control Oesophageal-Gastric pH and Reduce Symptoms of Gastric Reflux and Hyperacidity.

NCT ID: NCT05023174 Enrolling by invitation - Clinical trials for Reflux, Gastroesophageal

Platelet Rich Plasma in Hiatal Hernia Repair

PPR-HHR
Start date: October 18, 2021
Phase: N/A
Study type: Interventional

Rationale: Gastroesophageal reflux disease (GERD) is a common disease caused by a dysfunctional lower esophageal sphincter and an abnormal esophageal hiatus or hiatal hernia. Approximately 30% of large hiatal hernias will recur after surgery, in part due to weak connective tissue at the hiatus. Platelet rich plasma (PRP) is a promising autologous therapy that may address this shortcoming by substantially enhancing wound healing of the hiatus after repair. Intervention: PRP will be applied to mesh used in hiatal hernia repair. Objectives: The objective of this study is to determine the efficacy of PRP in hiatal hernia compared to traditional hernia repair without PRP. Study population: 150 patients 18 years and older with large (>5cm) paraesophageal hernias. Study methodology and study arms: a 1:1 allocation ration will be used to randomly assign 75 patients to the experimental arm (PRP with mesh) and 75 patients to the control arm (mesh only). Study outcomes: The primary outcome will be 1-year postoperative hernia recurrence based on video esophagram and/or upper endoscopy. The secondary outcome will be GERD-Health Related Quality of Life (GERD-HRQL) scores and dysphagia scores at 6 and 12 months. Follow-up: Patients who undergo fundoplication and hiatal hernia repair with mesh are seen in clinic for follow-up at two weeks, six weeks, six months, one year, and annually thereafter. Video esophagram or upper endoscopy will be performed at 1 year after surgery to assess the primary outcome. The investigators secondary outcome of reduction in GERD-HRQL score will be determined by a difference in the GERD-HRQL score from the preoperative score to the postoperative scores taken at 6 months and 1 year. The investigators secondary outcome of dysphagia will be determined by EAT-10 scores taken at 6 months and 1 year. Statistics/Analysis: Descriptive statistics will be used. Intention to treat and per protocol analyses will be performed. Frequentist and Bayesian statistical analyses will be used to determine statistically and clinically important outcomes.

NCT ID: NCT05004155 Recruiting - Esophagitis Clinical Trials

Twenty Four Hour Ambulatory pH & Impedance Testing: Normative Data for Indian Population

Start date: June 1, 2021
Phase:
Study type: Observational

GERD is common in Indian population and the normative data which is used to diagnose & manage GERD and its complications are based on western data which is not validated in the Indian population. Although normative data is available for commonly used twenty-four impedance-pH parameters, their global application has limitations, stemming from use of small healthy volunteer cohorts from few countries for normative data. At present, there is no normative data for twenty-four hours impedance-pH monitoring in Indian population. The aim of this study is to obtain a new set of normal values specific for the Indian population.

NCT ID: NCT04994665 Recruiting - Obesity Clinical Trials

Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy

Sleevepexie
Start date: December 7, 2021
Phase: N/A
Study type: Interventional

The aim of the study is to assess impact of omentopexy on de novo gastro-oesophageal reflux disease (GERD) after sleeve gastrectomy. This will be assess 2 years postoperatively. This study is a prospective, multicentric, randomized trial. Five hundred twenty six patients should be included with 263 in each arm. First arm will include patients who have a sleeve gastrectomy. The second arm will include patients who have sleeve gastrectomy with omentopexy. Two years after surgery , it will be collected a CARLSSON score and BAROS score (quality of life). The main objective is to show that omentopexy decreases the rate of de novo GERD after sleeve gastrectomy at 2 years postoperatively without the use of Proton-Pump Inhibitors (PPIs)

NCT ID: NCT04988347 Completed - Dyspepsia Clinical Trials

Spirulina Platensis for PPI Withdrawal

SpAReDPPI
Start date: November 2010
Phase: Phase 2
Study type: Interventional

Background: Rebound acid hypersecretion after proton pump inhibitors (PPIs) discontinuation may be accompanied by dyspepsia. Aim: To assess whether Spirulina platensis, by its anti-inflammatory properties, could minimize rebound symptoms after PPIs withdrawal.

NCT ID: NCT04984304 Recruiting - Asthma Clinical Trials

Individualized Diagnosis and Treatment of Extraesophageal Reflux in Patients With Chronic Cough

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

Chronic cough is a very unpleasant symptom, significantly reduces the patient's quality of life, and bothers the neighborhood. A very common cause or co-factor of chronic cough is extraesophageal reflux (EER). The aim of the project is the precise diagnosis of EER in patients with chronic cough (in patients with a simultaneously diagnosed allergic cause and without it).