Symptoms and General Pathology

All Conditions

Digestive System Diseases

Ear, Nose, and Throat Diseases

Ulcer

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Peptic Ulcer

Esophageal Motility Disorders

Esophageal Spasm, Diffuse

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Esophageal Diseases

Gastrointestinal Diseases

Signs and Symptoms, Digestive

Duodenal Diseases

Intestinal Diseases

Stomach Diseases

Anti-Infective Agents

All Drugs and Chemicals

Carbamide Peroxide

Magnetically controlled capsule endoscopy will be performed before UGI endoscopy.

Mangetically controlled capsule endoscopy will be performed

MCCE

The combined diagnostic accuracy of MCCE and UBT in Hong Kong patients with uninvestigated dyspepsia between age 35 to 60 years for structural pathology and HP infection is comparable to that of conventional UGI endoscopy with histological examination for HP

Dyspepsia affects about 20% of the population globally and represents one of the commonest reasons for patients to seek medical consultation.1-3 The definition of dyspepsia has evolved over time and generally encompasses a variety of upper gastrointestinal (UGI) symptoms that can be of anatomical or functional origin such as epigastric pain or burning, bloating, postprandial fullness, belching, early satiety and nausea.2, 4 While diagnostic criteria (eg, Rome IV criteria) have been proposed to better characterize and standardize symptoms of functional dyspepsia for research purpose, there is considerable overlap of clinical presentation between functional dyspepsia and organic / anatomical causes of dyspeptic symptoms such as peptic ulcer disease (PUD), gastroesophageal reflux disease (GERD), UGI malignancies, or pancreatobiliary diseases.2, 3, 5, 6 Therefore, it is of clinical importance to differentiate clinically significant anatomical pathologies from functional disorders during the initial evaluation of patients with dyspeptic symptoms.

Society guidelines based on Western population data with a relatively lower prevalence of helicobacter pylori (HP) and UGI cancers (eg, cancer of stomach, esophagus) generally recommend an initial noninvasive management approach (eg, "test and treat" strategy for HP and empiric trial of acid suppressive therapy) in dyspeptic patients without alarming symptoms or age \< 50 - 60, and reserve upfront endoscopy for high-risk patients with alarming symptoms (eg, gastrointestinal bleeding, iron deficiency anemia, dysphagia, unintended weight loss, etc) or age ≥ 50 - 60.2, 3 However, in Asian populations with a relatively higher prevalence of HP and UGI cancers, an initial noninvasive management approach to dyspeptic symptoms based on alarming symptoms and age cutoff at 50 - 60 years may not be entirely appropriate since up to 25% of patients with UGI cancers may not have alarming symptoms.7 In a recent systematic review with meta-analysis of dyspepsia management in Asian countries, alarming symptoms and age were found to be poor predictors of UGI cancers and 17.8% of dyspeptic patients who were eventually diagnosed with UGI cancers were younger than age 45.6

In a study of 5066 UGI endoscopies performed in Asian patients with dyspepsia, clinically significant structural pathologies (PUD, cancers of stomach / esophagus, esophagitis) were found in 19.5% of patients.8 Although UGI endoscopy is the gold standard for diagnosis of clinically significant structural pathologies and HP infection by histology, it is an invasive procedure with a small but finite risk of complication.3 When compared to the invasive nature of conventional UGI endoscopy, an initial minimally invasive diagnostic approach that can evaluate for both UGI structural pathology and HP infection would be highly desirable and clinically relevant in Asian patients with uninvestigated dyspepsia between 35 to 60 years of age.

Wireless capsule endoscopy (CE) (commonly known to the general public as the "pill camera") represents a minimally invasive diagnostic modality for visualization of the gastrointestinal (GI) tract and is well tolerated by patients.9 While conventional CE has been shown to provide adequate visualization of luminal pathologies in the small bowel, colon and esophagus, visualization of the different parts of stomach by conventional CE remains challenging due to its passive propulsion through the GI tract by peristalsis or gravity and the large cavity size of the stomach. Recently, magnetically controlled capsule endoscopy (MCCE) systems comprised of small capsule endoscope, guidance magnet robot, data recorder, and computer workstation for real-time viewing and control of CE have become available and can provide a more controlled visualization of different anatomical parts of the stomach by CE.10, 11 In a study of 350 patients with UGI symptoms requiring conventional UGI endoscopy for evaluation, MCCE was shown to be safe and was able to provide adequate visualization of the stomach with a high sensitivity (90.4%) and specificity (94.7%) for focal gastric lesions when compared with conventional UGI endoscopy.11 However, despite its promising role as a minimally invasive diagnostic modality for structural pathologies of stomach, MCCE does not allow tissue acquisition and thus cannot provide information on HP infection status by rapid urease test (RUT) or histological examination. On the other hand, noninvasive test for HP by urea breath test (UBT) has been shown to be highly sensitive and specific for HP infection and can supplement MCCE to provide important information on the status of HP infection.12

To date, there has been no dedicated study on the use of combined MCCE and UBT for minimally invasive evaluation of dyspepsia in Asian population. In order to address the gap in knowledge, we would like to propose a pilot prospective cohort study to investigate the clinical utility of combined MCCE and UBT as the initial minimally invasive evaluation of uninvestigated dyspepsia in Hong Kong patients between 35 to 60 years of age.

Minimally Invasive Evaluation of Dyspepsia by Combined Magnetically Controlled Capsule Endoscopy and Urea Breath Test: a Pilot Prospective Cohort Study

The combined diagnostic accuracy of MCCE and UBT in Hong Kong patients with uninvestigated dyspepsia between age 35 to 60 years for structural pathology and HP infection using conventional UGI endoscopy and histological examination for HP as gold standard

The sensitivity and specificity of MCCE for clinically significant structural pathology in UGI (defined as peptic ulcers, cancers, reflux esophagitis) in Hong Kong patients with uninvestigated dyspepsia between age 35 to 60 years using conventional UGI endoscopy as gold standard

The sensitivity and specificity of UBT for HP infection in Hong Kong patients with uninvestigated dyspepsia between age 35 to 60 years using histological examination for HP by UGI endoscopy as gold standard

Adverse events up to 2 weeks after UBT, MCCE, UGI endoscopy

Chinese University of Hong Kong

Assitant Professor

Neoplasms

Infections

Rare Diseases

Stomach Neoplasms

Communicable Diseases

Gastritis

Gastroenteritis

Stomach Cancer

Gastrointestinal Agents

Amoxicillin

Esomeprazole

Bismuth

Clarithromycin

Anti-Bacterial Agents

Antacids

Anti-Ulcer Agents

Proton Pump Inhibitors

Enzyme Inhibitors

Cytochrome P-450 CYP3A Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Esomeprazole Enteric Tablets 40mg, 3 times/day; Amoxicillin Capsules 1000mg, 3 times/day.The course of all drugs is two weeks.

Esomeprazole Enteric Tablets 40mg, 2 times/day; Amoxicillin Capsules 1000mg, 2 times/day; Clarithromycin Tablets 500mg, 2 times/day; Colloidal Bismuth Tartrate Capsules 220mg, 2 times/day.The course of all drugs is two weeks.

High-dose dual therapy: given for 14 days at a dose of esomeprazole 20mg 2 tablet TID plus amoxicillin 500 mg 2 capsules TID

High-dose dual therapy: given for 14 days at a dose of amoxicillin 500 mg 2 capsules TID plus esomeprazole 20mg 2 tablet TID

Bismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2 capsules BID plus esomeprazole 20 mg 2 tablets BID, amoxicillin 500mg 2 capsules BID and clarithromycin 250mg 2 tablets BID

BBismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2 capsules BID plus esomeprazole 20 mg 2 tablets BID, amoxicillin 500mg 2 capsules BID and clarithromycin 250mg 2 tablets BID

Tengteng Wang

Yongquan Shi, Ph. D

This study was conducted to investigate the effects of high-dose diphtherapy and bismuth quadruple therapy on H. pylori eradication on intestinal microecology, to clarify the changes in intestinal microbiota diversity and structure before and after the two treatment regimens, and to explore the relationship between different treatment regimens and intestinal microbiota dysbiosis; to further guide the safety and drug resistance of H. pylori eradication by the two treatment regimens. The expected results are to observe the changes of intestinal microbiota diversity and structure before and after treatment with the two treatment regimens.

The trial can be divided into three phases.

1. Enrollment screening phase: patients who had been clearly diagnosed with Hp infection and had not received antibiotic therapy and met the inclusion and exclusion criteria were informed and signed informed consent forms, their basic data information was collected, medical history and laboratory tests before enrollment were taken; if they met the requirements of the trial protocol they were included in the study, and patients' stools were collected for 16S rRNA gene sequencing.
2. Treatment period: Patients were enrolled according to a randomized number table provided in advance by a third party, and patients were randomized in a 1:1 ratio to high-dose diphtherapy and bismuth quadruple therapy to receive 2 weeks of Hp eradication treatment. During the treatment period, patients were provided with written instructions on how to take the medication, instructed on the correct way to take the medication, and improved their compliance; patients were asked to record their symptoms and adverse reactions during the medication period, and were informed of the visiting telephone number and visiting WeChat, so that they could keep in touch with the investigator at any time.
3. Follow-up period: At the end of treatment (i.e., day 14 from the start of treatment), patients were asked to return at that time to have their stools sequenced for 16S rRNA gene, and 6 weeks after the end of treatment (i.e., day 56 from the start of treatment), patients were asked to return at that time to undergo rapid urease test (RUT), 13C/14C-urea breath test (13C/14C-UBT), or fecal Hp antigen test. ) or fecal Hp antigen assay (HpSA), with the results recorded on a CRF form, and the patient's stool collected for 16S rRNA gene sequencing.

Effects of High-dose Dual Therapy and Bismuth Quadruple Therapy for Helicobacter Pylori Eradication on Intestinal Microecology

Feces from subjects before treatment , after eradication treatment , and at week 6 after eradication treatment were analyzed for gut microbiota diversity by 16S rRNA gene sequencing, including alpha diversity (representing the abundance of species in the microbial ecosystem, i.e., the number of different species, and evenness, i.e., similar abundance or dominance of some species over others) and beta diversity (representing the difference in microbial composition in one environment compared to another).We will explore the changes in intestinal microbiota diversity and structure before and after treatment with both treatment regimens.

The end point of this study is H.pylori eradication，established by negative \[13C\] urea breath test （DOB value below 3.9）28 days after the end of eradication.

Xijing Hospital of Digestive Diseases

professor

Tetracycline

Furazolidone

Anti-Infective Agents, Local

Antiprotozoal Agents

Antiparasitic Agents

Monoamine Oxidase Inhibitors

Esomeprazole 40 mg and amoxicillin 1000 mg by mouth，three time daily for 14 days

Tetracycline 500mg three time daily for 14 days，furazolidone 100 mg, esomeprazole 40 mg, and Bismuth 220mg by mouth, twice daily for 14 days.

High-dose esomeprazole and amoxicillin dual therapy: given for 14 days at a dose of esomeprazole 40mg 1 tablet TID plus amoxicillin 500 mg 2 capsules TID

High-dose esomeprazole and amoxicillin dual therapy: given for 14 days at a dose of amoxicillin 500 mg 2 capsules TID plus esomeprazole 40mg 1 tablet TID

Bismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2 capsules BID plus esomeprazole 40 mg 1 tablets BID，tetracycline 250mg 2 capsules TID and furazolidone 100mg 1 tablets BID

Bismuth-containing quadruple therapy: given for 14 days at a dose of esomeprazole 40mg 1 tablet BID plus bismuth 110 mg 2 capsules BID，tetracycline 250mg 2 capsules TID and furazolidone 100mg 1 tablets BID

Bismuth-containing quadruple therapy:given for 14 days at a dose of tetracycline 250mg 2 capsules TID plus furazolidone 100mg 1 tablets BID，esomeprazole 40 mg 1 tablets BID and bismuth 110 mg 2 capsules BID

Bismuth-containing quadruple therapy:given for 14 days at a dose of furazolidone 100mg 1 tablets BID plus tetracycline 250mg 2 capsules TID，esomeprazole 40 mg 1 tablets BID and bismuth 110 mg 2 capsules BID

This study aims at evaluating efficacy and safety of high-dose esomeprazole and amoxicillin dual therapy(esomeprazole and amoxicillin) versus bismuth-containing quadruple Therapy(bismuth，esomeprazole，tetracycline and furazolidone) in H. pylori rescue therapy. It is hypothesized that high-dose esomeprazole and amoxicillin dual therapy is non-inferior to bismuth-containing quadruple Therapy. Patients with confirmed failure of H. pylori eradication will be randomized to one of the treatments described above. At week 6 follow-up visits, a urea breath test，rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.

The study will include three phases: screening, treatment and follow-up.

Screening: this phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing informed consent. One of urea breath test，rapid urease test or helicobacter pylori stool antigen test will be performed in addition to the baseline routine evaluations.

Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 14 and 16.

Follow-up: includes one visits. Approximately 28 days after the end of treatment. Eradication of H. Pylori will be confirmed by one of urea breath test，rapid urease test or helicobacter pylori stool antigen test.

Helicobacter Rescue Therapy With High-dose Esomeprazole and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy

Rescue Therapy for Helicobacter Pylori Eradication: A Randomized and Non-inferiority Trail of High-dose Esomeprazole and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy

The primary end point of this study is H.pylori eradication，established by negative \[13C\] urea breath test （DOB value below 3.9）28 days after the end of eradication

symptoms improvement rates Evaluation improvement rate of symptoms 2 weeks of treatment and 4 weeks after the end of treatment. Symptom improvement rate =#total score before treatment - total score after treatment#/total score before treatment x100%. Total score = frequency + severity.Frequency score is calculated by all the frequency of heartburn, reflux, abdominal pain, and flatulence, etc. Severity is accumulated by the degree of symptoms described above, which is divided to 4 degree as 0 presenting none, and 3 presenting most severe

Participants with Adverse Events as a Measure of Safety and Tolerability.The common side effects of the study include headache,dizziness,skin rash,other gastrointestinal disorders,pyrexia,cough and back pain.

Professor

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Mouth and Tooth Diseases

Breast Neoplasms

Lung Neoplasms

Mucositis

Glucagon

Glucagon-Like Peptide 1

Before starting and at the end of the chemotherapy, along with a blood withdrawal for GLP-2 evaluation, a GSRS (gastrointestinal symptom rate scale) questionnaire will be filled by each patient to account for GI symptoms. In addition, minor complaints such as warm sensation after chemotherapy, susceptibility to nausea under specific condition, sweating and weakness will scored by visual analog score (VAS). Lastly, the NCI-CTC score for mucositis will be performed.

Caterina Clemente, ScD

The specific aim of the study is to investigate the relationship between the development of dyspepsia and GI dyspeptic symptoms in relation to circulating levels of peculiar GI peptides (such gastrin, pepsinogen and GLP-2) in patients with non-gastrointestinal neoplasm well controlled for emesis.

The complications of anticancer treatment threaten the effectiveness of therapy because they lead to dose reduction, increase healthcare costs, and impair patients' quality of life. Gastrointestinal (GI) symptoms are the most frequent side effects of antineoplastic chemotherapy behind bone-marrow depression, with nausea and vomiting representing the mainly referred ones.

Gastrointestinal (GI) mucositis, which represents injury of the rest of the alimentary tract beyond oral mucositis, is becoming recognized increasingly as a toxicity associated with many standard-dose chemotherapy regimens. Although clinicians consider them "minor complaints", many patients (40-100%) treated with chemotherapy and/or exposed to ionizing radiation suffer from such a disease. After chemotherapy, GI mucositis is most prominent in the small intestine, but it also occurs in the esophagus, stomach, and large intestine. The GI symptoms related to mucositis mimic those from other GI disease (such as dyspepsia, reflux disease or abdominal pain and diarrhea). Alimentary tract mucositis increases morbility and mortality and contribute to rising health care cost.

The comprehension of pathophysiology will shed light on the rationale for targeting specific pathways and so for the use of specific agents for prevention and treatment. Since the role of chemotherapy in the onset of GI motility disorders in addition to minor GI complaints has not been clarified yet. Understanding the pathophysiology of mucositis, its measures and scores, are essential for progress in research and care direct at this common side-effect of anticancer therapy. Currently, there is not strong evidence to support a recommendation for and against the use of certain agents (mucosal surface protectants, antiinflammatory or antimicrobial agents, growth factors, etc).

Plasma Levels of Glucagon-like Peptide-2 and Dyspepsia in Patients With Extraintestinal Cancer During Chemotherapy

Evaluation of Dyspeptic Symptoms in Oncological Frail Patients With Extraintestinal Cancer in Chemotherapy. Assessment of Circulating Levels of Glucagon-like Peptide 2 (GLP-2) in Relation to Mucositis

Evaluation of plasma levels of GLP-2 in patients with extraintestinal cancer before and after chemotherapy.

Evaluation of the symptom profile related to CADS (cancer associated dyspepsia syndrome) before and after the first cycle of chemotherapy.

Assessment of possible relations between mucositis score, gastrointestinal symptom score and GLP-2 plasma levels.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Minimally Invasive Evaluation of Dyspepsia by Combined Magnetically Controlled Capsule Endoscopy and Urea Breath Test: a Pilot Prospective Cohort Study	NCT04918472	Dyspepsia Peptic Ulcer Di... Gastroesophagea... Ugi Malignancie... Pancreatobiliar...	MCCE	35 Years - 60 Years	Chinese University of Hong Kong
Minimally Invasive Evaluation of Dyspepsia by Combined Magnetically Controlled Capsule Endoscopy and Urea Breath Test: a Pilot Prospective Cohort Study	NCT04918472	Dyspepsia Peptic Ulcer Di... Gastroesophagea... Ugi Malignancie... Pancreatobiliar...	MCCE	35 Years - 60 Years	Chinese University of Hong Kong
Effects of High-dose Dual Therapy and Bismuth Quadruple Therapy for Helicobacter Pylori Eradication on Intestinal Microecology	NCT05742568	Gastritis Dyspepsia Helicobacter Py... Gastric Cancer Peptic Ulcer	Esomeprazole Amoxicillin Bismuth Esomeprazole Amoxicillin Clarithromycin	18 Years - 70 Years	Xijing Hospital of Digestive Diseases
Helicobacter Rescue Therapy With High-dose Esomeprazole and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy	NCT04678492	Gastritis Dyspepsia Helicobacter Py... Gastric Cancer Peptic Ulcer	Esomeprazole Amoxicillin Bismuth Esomeprazole Tetracycline Furazolidone	18 Years - 70 Years	Xijing Hospital of Digestive Diseases
Helicobacter Rescue Therapy With High-dose Esomeprazole and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy	NCT04678492	Gastritis Dyspepsia Helicobacter Py... Gastric Cancer Peptic Ulcer	Esomeprazole Amoxicillin Bismuth Esomeprazole Tetracycline Furazolidone	18 Years - 70 Years	Xijing Hospital of Digestive Diseases
Minimally Invasive Evaluation of Dyspepsia by Combined Magnetically Controlled Capsule Endoscopy and Urea Breath Test: a Pilot Prospective Cohort Study	NCT04918472	Dyspepsia Peptic Ulcer Di... Gastroesophagea... Ugi Malignancie... Pancreatobiliar...	MCCE	35 Years - 60 Years	Chinese University of Hong Kong
Plasma Levels of Glucagon-like Peptide-2 and Dyspepsia in Patients With Extraintestinal Cancer During Chemotherapy	NCT01382667	Breast Cancer Lung Cancer Dyspepsia		18 Years - 70 Years	Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Minimally Invasive Evaluation of Dyspepsia by Combined Magnetically Controlled Capsule Endoscopy and Urea Breath Test: a Pilot Prospective Cohort Study	NCT04918472	Dyspepsia Peptic Ulcer Di... Gastroesophagea... Ugi Malignancie... Pancreatobiliar...	MCCE	35 Years - 60 Years	Chinese University of Hong Kong

Spots Global Cancer Trial Database for dyspepsia

Every month we try and update this database with for dyspepsia cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for dyspepsia

Every month we try and update this database with for dyspepsia cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for dyspepsia cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.