Prediction of Post-laparoscopic Sleeve Gastrectomy Gastroesophageal Reflux Disease With an Endolumenal Functional Lumen Imaging Probe (EndoFLIP)
Researchers are trying to identify predictors for gastroesophageal reflux disease after sleeve gastrectomy.
NCT04411823 — Gastroesophageal Reflux
Status: Recruiting
http://inclinicaltrials.com/gastroesophageal-reflux/NCT04411823/
Gracie Diet for Gastroesophageal Reflux Disease
GERD, is a common and chronic world-wide disease. Cardinal symptoms of this condition are heartburn-regurgitation, and sometimes with extra-intestinal symptoms that can affect patients' quality of life. Proton pump inhibitors (PPIs) potently inhibit gastric acid secretion and are widely used for treatment of acid-related diseases. This class of medications is the most widely used for the management of GERD. H2 Receptor Antagonists (H2RAs) are another type of medication used to of uncomplicated GERD, gastric or duodenal ulcers, gastric hypersecretion, and for mild to infrequent heartburn or indigestion. H2RAs decrease gastric acid secretion by reversibly binding to histamine H2 receptors located on gastric parietal cells, thereby inhibiting the binding and action of the endogenous ligand histamine. Dietary modification is endorsed by the National Institutes of Health and the American College of Gastroenterology as a first-line therapy for patients with GERD. The Gracie Diet is thought to play an important role in the prevention of GERD. The concept behind this diet is that the consumption of proper food combinations promotes optimal health by preventing unhealthy chemical reactions in the digestive process such as fermentation and acidity. This diet describes the benefits of combining different foods together and the downsides of combining others. It provides guidance on avoiding specific foods and combinations of foods that may aggravate GERD, and adopting meal spacing habits to improve overall health outcomes. The idea is that such dietary changes support more efficient digestion and encourage healthier lifestyles (i.e. smoking cessation, elimination of alcohol intake, avoidance of soda consumption and desserts). This diet also supports the acquisition of healthy eating habits characterized by higher consumption of fruits, vegetables, and whole grains, and encourages a reduction in the intake of saturated fat, sodium, added sugars, and canned foods. Limiting beverage consumption of water or fresh coconut water between meals is also encouraged. In this pilot study, the investigators hypothesized that the Gracie diet it could be an alternative option to improve GERD symptoms in those patients who do not respond to standard doses of PPI and/or H2 receptor antagonists.
NCT04360252 — Gastroesophageal Reflux
Status: Recruiting
http://inclinicaltrials.com/gastroesophageal-reflux/NCT04360252/
Randomized Double-Blind Clinical Trial of Tongjiang Theory and Syndrome Differentiation Serial Prescriptions Combined With Proton Pump Inhibitors(PPIs)Descending Ladder Withdrawal for the Treatment of Nonerosive Reflux Disease.
Nonerosive Reflux Disease (NERD) is a common refractory gastrointestinal disease. Proton Pump Inhibitors (PPIs), the preferred drug, have poor response, single target and poor acid inhibition effect in some patients in clinical application. Long-term use of PPI can lead to many side effects, even dependency. The main Traditional Chinese Medicine (TCM)syndrome types of NERD are liver-stomach depression-heat syndrome, spleen deficiency damp-heat syndrome and cold-heat complicated syndrome. TCM syndrome differentiation treatment has the advantages of overall regulation and individualized treatment. The purpose of this study is to evaluate the safety and efficacy advantages of syndrome differentiation series prescription combined with PPIs descending ladder withdrawal in the treatment of patients who use PPIs for a long time that can not stop, and to solve the problems of multiple side effects and dependency caused by long-term use of PPIs.
NCT04340297 — Nonerosive Reflux Disease
Status: Recruiting
http://inclinicaltrials.com/nonerosive-reflux-disease/NCT04340297/
A Multicenter, Randomized, Parallel, Double-Blinded, Placebo-controlled Phase 3 Study to Compare Efficacy and Safety of HIP1601 in Patients With Non-Erosive Gastroesophageal Reflux Disease(NERD)
The purpose of this study is to investigate the safety and clinical efficacy of HIP1601 in patients with Non-erosive gastroesphageal reflux disease.
NCT04325620 — Non-erosive Gastroesphageal Reflux Disease
Status: Completed
http://inclinicaltrials.com/non-erosive-gastroesphageal-reflux-disease/NCT04325620/
Efficacy and Safety of Jianpi Qinghua Granules in Patients With Nonerosive Reflux Disease:a Multicenter,Randomized, Double-blind, Placebo-controlled Clinical Trial
Nonerosive reflux disease (NERD) is a common refractory gastrointestinal disease. Proton pump inhibitors (PPIs), the first choice drug, have the following problems in clinical use: about 50 % of patients have no response to PPIs; the efficacy of simple acid suppression is poor; long-term use of PPIs can lead to indigestion, gastric polyps, atrophic gastritis, intestinal dysbacteriosis. Spleen Deficiency and Damp-heat Syndrome is one of the common clinical syndrome of NERD.TCM syndrome differentiation and treatment has the advantages of overall regulation and individualized treatment, but lack of high-level evidence. The purpose of this study is to evaluate the efficacy and safety of Jianpi Qinghua Granules for treating NERD with spleen deficiency and damp heat syndrome.
NCT04324138 — Nonerosive Reflux Disease
Status: Recruiting
http://inclinicaltrials.com/nonerosive-reflux-disease/NCT04324138/
Using the Paediatric Gastroesophageal Reflux Disease Symptom and Quality of Life Questionnaire (PGSQ) in Children With Cerebral Palsy: a Preliminary Validation Study
This study assesses the content validity of the PGSQ for parents/carer of children with cerebral palsy and GORD, including features such as readability, face validity and acceptability for completion. This will be done via 6 interviews, with the PGSQ being altered as identified as required. Reliability (test-retest) of the adapted version of the PGSQ being assessed with a sample of 20 parents/carers.
NCT04293107 — Quality of Life
Status: Recruiting
http://inclinicaltrials.com/quality-of-life/NCT04293107/
A Monocentric Randomized Controlled Prospective Study to Evaluate the Antireflux Efficacy of Primary Crural Closure During Sleeve Gastrectomy for Obese Patients With Incompetents Oeso-gastric Valves
This is a monocentric randomized controlled prospective study. A total of 122 patients will be recruited and randomized 1: 1 in the experimental group - Laparoscopic Sleeve Gastrectomy and Diaphragmatic Pillar Closure - or in the control group - Laparoscopic Sleeve Gastrectomy. At 6 months post surgery a gastroscopy, an oesophageal manometry and a PH-study will be perform to detect de novo GastroEsophageal Reflux Disease and hiatal hernia appearance.
NCT04287972 — Obesity
Status: Withdrawn
http://inclinicaltrials.com/obesity/NCT04287972/
Near Focus NBI-Driven Artificial Intelligence for the Diagnosis of Gastro-Oesophageal Reflux Disease
Gastro-oesophageal reflux disease (GORD) is a chronic condition with symptoms arising secondary to the reflux of stomach contents (Vakil et al., 2006). It is divided into four phenotypes: Erosive Oesophagitis (EO), Non-Erosive Reflux Disease (NERD), Reflux Hypersensitivity (RH), Functional Heartburn (FH) (Nikaki, Woodland and Sifrim, 2016). The definition of these phenotype have evolved with the addition of diagnostic tests and methods of their interpretation, the most recent being the Lyon Consensus Statement (Gyawali et al., 2018). The majority of patients presenting with symptoms suggestive of GORD have no mucosal lesion seen at endoscopy (Nikaki, Woodland and Sifrim, 2016). Studies have shown a relation of increased IPCL numbers with GORD. This study aims to build a fully autmoated AI model using Near-Focus NBI images on patients with symptoms suggestive of GORD phenotyped in accordance with the Lyon Consensus.
NCT04268719 — Gastro Esophageal Reflux
Status: Completed
http://inclinicaltrials.com/gastro-esophageal-reflux/NCT04268719/
Real-life Study of Changes of Gastroesophageal Reflux Disease Manifestations Due to Behavioural and Diet Adherence
This study is aimed to investigate the role of long-term diet adherence on manifestations of gastroesophageal reflux disease
NCT04255693 — Gastroesophageal Reflux Disease
Status: Recruiting
http://inclinicaltrials.com/gastroesophageal-reflux-disease/NCT04255693/
A Randomized Single Blinded Parallel Study to Investigate the Physiological Modulation of the Autonomic Nervous System on Symptoms in Patients With Reflux Hypersensitivity
Reflux hypersensitivity is the disease that causes chest pain, heartburn and regurgitation and can impair patients' quality of life. Pain modulators are often used for the treatment of reflux hypersensitivity, but the effect is not enough and more effective therapy is needed. Slow deep breathing is the validated method to modulate the autonomic nervous system. In our previous study, slow deep breathing could increase the threshold of oesophageal pain in healthy volunteers. Therefore, slow deep breathing has the potential to be an effective treatment for reflux hypersensitivity and further study is warranted in the patient group. The aims of this study are (1) to evaluate the feasibility of slow deep breathing and (2) to investigate the effect of autonomic nerve modulation by slow deep breathing on symptoms in patients with reflux hypersensitivity.
NCT04253444 — Gastro Esophageal Reflux
Status: Completed
http://inclinicaltrials.com/gastro-esophageal-reflux/NCT04253444/