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Esophagitis clinical trials

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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: NCT06159218 Recruiting - Clinical trials for Eosinophilic Esophagitis

Eosinophilic Oesophagitis Assessment With String Testing

EoEAST
Start date: November 9, 2022
Phase: N/A
Study type: Interventional

Eosinophilic oesophagitis (EoE) is an inflammatory condition of the oesophagus (food pipe) that can lead to difficulty swallowing and to food to getting stuck and has become increasingly common over the past 40 years. EoE is triggered by a protein in the diet but alterations to the types of bacteria (microbiome) in the oesophagus may also be involved. EoE is diagnosed with gastroscopy (a thin camera test via the mouth) where 6 tiny samples (biopsies) are taken. Treatment is either with removing food groups from the diet or medications including steroids (budesonide) or a proton pump inhibitor (PPI, omeprazole). The aim is to improve symptoms and to stop scar tissue forming that can cause food to get stuck. Patients with EoE will need to undergo many gastroscopies over their life, which even with sedation can be a daunting experience. There has been research into less invasive tests and two previous studies have shown that a thin swallowed string may be able to detect substances (biomarkers) that indicate how severe the EoE is. These studies were small and it is not known how the biomarkers change with different treatments or how well they relate to symptoms and findings with endoscopy. In this study the investigators will ask adults with EoE to swallow a thin string made of rayon for 30 minutes, with one end taped to the cheek, which the investigators will analyse for biomarkers and bacteria, on the same day as their routine gastroscopy and also perform a symptom survey. The investigators will also take an extra 2 biopsies to analyse the nerves which may explain why some patients have more symptoms than others. The investigators will repeat the string test on their next endoscopy, to assess what the changes have been in response to their treatments. These findings may improve understanding on how to monitor EoE in less invasive ways in future.

NCT ID: NCT06120803 Recruiting - Clinical trials for Locally Advanced Lung Carcinoma

Esomeprazole and Radiation Induced Esophagitis

EERENs
Start date: March 1, 2024
Phase: Phase 2
Study type: Interventional

Thoracic radiation therapy combined with chemotherapy (with or without immunotherapy) is the cornerstone of management in patients with locally advanced non-small cell lung cancer (NSCLC).

NCT ID: NCT06101095 Recruiting - Clinical trials for Eosinophilic Oesophagitis

A Study Assessing Esophageal Function and Remodeling With Dupilumab Compared With Placebo for 24 Weeks Followed by 104 Weeks Open Label in Adult Participants With EoE (REMOdeling With Dupilumab in Eosinophilic Esophagitis Long-term Trial)

Start date: November 29, 2023
Phase: Phase 4
Study type: Interventional

This is parallel, Phase 4 study which consists of a 24 week (0.5 years) randomized, double blind, placebo controlled, 2-arm treatment period followed by an open label segment of 104 weeks (2 years) for a total of 128 weeks (2.5 years) to evaluate the effect of dupilumab treatment on esophageal function, and remodeling in adults with eosinophilic esophagitis. Duration of study period (per participant) - Screening period: Up to 12 weeks before Week 0 - Randomized double-blind period: 24 weeks - Open label period: 104 weeks - Post Investigational Medicinal Product (IMP) intervention follow-up period: up to 12 weeks or until the participants switch to commercialized dupilumab, whatever comes first. There will be ten (10) site visits, and five (5) direct-to-participant IMP delivery visits (except if prohibited by local regulatory authorities or if participant is not willing. In this case, IMP will be dispensed at the study site).

NCT ID: NCT06093204 Recruiting - Clinical trials for Esophagitis, Eosinophilic

The Potential Role of Compounds Derived From Ultra-processed Foods in Pathogenesis of Eosinophilic Esophagitis

Start date: April 12, 2023
Phase:
Study type: Observational

Eosinophilic esophagitis (EoE) is a chronic antigen-mediated inflammatory disease of the esophagus that affects both children and adults. The incidence and prevalence of EoE is rapidly increasing in Western countries with an estimated incidence of 6.6 per 100,000 person-years (95% CI, 3-11.7) in children and 7.7 per 100,000 person-years (95% CI, 1.8-17.8) in adults. Clinically, it is characterized by various symptoms related to esophageal dysfunction, including vomiting, regurgitation, feeding difficulties, epigastric heartburn, dysphagia, or food bolus impaction, and may cause growth retardation. Diagnosis is made on the basis of clinical symptoms and histological evidence of eosinophilic infiltration of the esophagus (at least 15 eosinophils/high power microscope field (eos /hpf), excluding other etiologies of esophageal eosinophilia (gastroesophageal reflux disease, infectious esophagitis, achalasia, celiac disease and Crohn's disease, connective tissue disorders, gra ft versus host disease, drug hypersensitivity and hypereosinophilic syndromes). EoE is primarily characterized by a T helper 2 type inflammation, but the pathogenesis and the immunopathological mechanisms underlying the pathology are not yet fully understood. Recent evidence suggests that in genetically predisposed individuals, interaction with environmental factors (e.g., dietary lifestyle) may play a role in activating several inflammatory pathways and cause EoE. Ultra-processed foods (UPFs) are food and beverage products resulting from industrial formulations, ready for consumption, typically obtained with five or more ingredients from different manufacturing processes (cooking methods, addition of additives such as stabilizers or preservatives). During the last decade, the consumption of the latter has increased significantly among the pediatric population to represent 30% of the daily caloric intake of an average child in Europe and America. Recent evidences show that UPFs favor the onset of chronic non-communicable diseases through the activation of different inflammatory pathways. The components mostly represented in UPFs are the advanced glycation end products (AGEs), a heterogeneous group of highly oxidizing compounds that are formed through non-enzymatic reactions (Maillard reaction) between reduced sugars and free amino groups of proteins, lipids, or nucleic acids. Evidence demonstrates that dietary AGEs are absorbed and contribute significantly to the total concentration of AGEs in the body. AGEs induce oxidative stress and inflammation, leading to structural and functional protein alterations, cellular apoptosis and multi-tissue/organ damage. These mechanisms are mediated at least in part by interactions with their cell-surface receptor for advanced glycation end-products (RAGE). The AGEs-RAGE interaction modulates the immune response. AGEs are able to activate le mast cells, to stimulate the release of histamine and to induce a chronic inflammatory state that promotes a T helper 2 type response.

NCT ID: NCT06071585 Not yet recruiting - Clinical trials for Eosinophilic Esophagitis

Monocentric Retrospective Observational Study for Validation of Meta-analysis of the Metatrascryptome and Transcriptome of Eosynophyl Esophagitis

Start date: November 1, 2023
Phase:
Study type: Observational

This is a retrospective monocentric observational study involving patients with Eosinophilic esophagitis (EoE), gastroesophageal reflux disease (GERD), and controls (patients without EoE and GERD). To validate the EoE-related markers obtained with the EoE TaMMA web app (such as CCL26, TBX5, NOX4, FGF7, CXCL14, ADAMTS5, PDGFRA, CXCL12, ACVRL1, POSTN, and LTBP4), we will stain and analyze EoE, GERD, and controls Formalin-fixed paraffin-embedded (FFPE) tissue samples already stored in the pathological laboratory of OSR. For this reason, this project will be accomplished thanks to the collaboration with prof. Doglioni's team at OSR.

NCT ID: NCT06062225 Not yet recruiting - Clinical trials for Postoperative Complications

Protocol for Comparing the Efficacy of Three Reconstruction Methods of the Digestive Tract After Proximal Gastrectomy

Start date: October 2023
Phase: N/A
Study type: Interventional

The efficacy of three different reconstruction methods after proximal gastrectomy will be investigated in this study through a prospective, multicenter, randomized controlled trial.

NCT ID: NCT06056973 Not yet recruiting - Reflux Esophagitis Clinical Trials

Jinghua Weikang Capsule in the Treatment of Reflux Esophagitis

Start date: October 1, 2023
Phase: Phase 4
Study type: Interventional

Reflux esophagitis is a common clinical disease ; pPI or potassium competitive acid blocker ( P-CAB ) is the first choice for the treatment of reflux esophagitis. However, patients with recurrent symptoms and severe esophagitis ( Los Angeles grade C and D ) after long-term use of PPI or P-CAB usually need long-term maintenance treatment. Attention should be paid to the possible adverse reactions of long-term acid suppression therapy and the interaction between drugs. The main efficacy of Jinghua Weikang capsules is regulating qi and dispersing cold, clearing heat and removing blood stasis. Applicable to cold and heat syndrome, qi stagnation and blood stasis caused by epigastric distension, pain, belching, acid reflux, noisy, bitter taste ; duodenal ulcer see the above syndrome. In the early stage, a series of studies were carried out on Jinghua Weikang Capsule, which confirmed that Jinghua Weikang Capsule showed the effect of acid inhibition and symptom relief in the treatment of reflux esophagitis, and had a synergistic effect when combined with western medicine. However, Jinghua Weikang Capsule still lacks sufficient evidence to support the reduction of the recurrence rate of reflux esophagitis. Therefore, we carried out this experiment to explore the clinical efficacy of Jinghua Weikang Capsule in the maintenance treatment of reflux esophagitis, so as to reduce the recurrence rate of reflux esophagitis and relieve symptoms.

NCT ID: NCT05900011 Recruiting - Clinical trials for Eosinophilic Esophagitis

Validation in French of a Quality of Life Questionnaire for Patients With Eosinophilic Esophagitis in Pediatrics

ValidEoE
Start date: July 17, 2023
Phase:
Study type: Observational

Eosinophilic esophagitis is a chronic condition of the esophagus. The symptoms of eosinophilic esophagitis can affect the quality of life of affected children. There is no French scale to specifically evaluate the quality of life of these patients. It will be a monocentric, prospective, descriptive study carried out at the Nice University Pédiatric Hospital. The main objective of this study will be the validation of a French version of the quality of life pediatric scale (PedsQL) module for eosinophilic esophagitis. It will take place in 2 distinct parts: - The translation of the questionnaire in French. - Collection of the quality of life questionnaires

NCT ID: NCT05899491 Recruiting - GERD Clinical Trials

Role of ARMA in Selective Subset of Refractory GERD Patients.

Start date: March 30, 2023
Phase: N/A
Study type: Interventional

To study the role of a novel endoscopic treatment technique (ARMA) in GERD patients who doesn't respond to PPI therapy (Proton Pump Inhibitor).