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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

Stomach Ulcer

Stomach Cancer

Anti-Bacterial Agents

SQ109

Frank Lanza, MD

Helicobacter pylori infection of the gastric epithelium is the most common bacterial infection worldwide. Its global prevalence is estimated at 50%, though the burden falls disproportionately on the developing world, where the prevalence in some areas is 80%. H. pylori infection is generally acquired during childhood, and without specific antibiotic treatment can persist for life. The infection is generally clinically asymptomatic during childhood, and even in adulthood 80-90% of infected individuals will remain asymptomatic (although they may transmit the bacteria).

SQ109 is a new, small molecule antibiotic with characteristics that make it particularly attractive to evaluate against H. pylori. In brief, SQ109 is orally bioavailable, acid-stable, has in vitro activity against H. pylori and achieves high intracellular concentration (which may be important to effect bacterial eradication).

Based on the antimicrobial activity and clinical safety, SQ109 will be evaluated in this clinical trial to assess safety and antimicrobial activity in adults infected with H. pylori. Data from this study will help determine whether larger safety and efficacy studies in individuals with H. pylori-associated duodenal ulcer disease are warranted.

A total of 30 Urea Breath Test (UBT)-Positive volunteers will be enrolled. Each subject will receive SQ109 150 mg bid with PPI or 300 mg qd by mouth daily for 14 consecutive days.

Major Inclusion/Exclusion Criteria:

1. Subject must be 18 to 45 years of age (inclusive).
2. Subject must have 2 positive Urea Breath Tests (UBT) obtaining during screening, and no other clinically significant disease (i.e., hematology, clinical chemistry and urinalysis tests must be within study-defined ranges. Clinical tests must be performed within 14 days of receiving first dose of study drug.
3. Body Mass Index (BMI) must be between 18 and 33 kg/m2 inclusive.
4. Subject must be able to give voluntary written informed consent before any study related procedure is performed.

Objectives:

1. To determine the safety and tolerability of SQ109 administered daily for 14 consecutive days in male and female Urea Breath Test (UBT)-positive subjects.
2. To assess antimicrobial activity against H. pylori of SQ109 administered daily for 14 days in UBT-positive subjects.

Design: Each subject will undergo screening evaluations within 14 days of study entry (Day 1) and baseline evaluations Day -14 and Day -2 to Day 1 (up to 14 days prior to the first dose). On Day 1 (first day of dosing), the subject will be administered study drug and undergo the Day 1 procedures. Throughout the 14 days of treatment phase of the study each subject will be assessed daily for adverse events (AEs). Laboratory safety evaluations will be performed on Day 7, 8, 9, or 10, and on Day 14, and Day 21. On Days 1, 4, 7, 10, 14, 21, and 28 each subject will have a UBT. On Follow-up Days 21 and 28 each subject will return to the study unit to have safety assessments.

Outcome Measures:

Safety and tolerability will be evaluated by a review of physical examinations, neurological examinations, vital signs assessments, 12-lead ECGs, routine clinical laboratory tests (including chemistry and hematology data), and AE assessments.

Efficacy Outcome Measures consist of serial UBT assessments for evidence of H. pylori in the gastrointestinal tract collected at baseline, during the 14 days of SQ109 administration, and during the 14 day follow-up period.

Evaluation of SQ109 Plus PPI in Urea Breath Test-Positive Volunteers

Phase 2A Open-label Study to Evaluate Safety, Tolerability, and Antimicrobial Activity of Single, Daily Doses of SQ109 in Urea Breath Test Positive Volunteers

In addition to assessment of safety and tolerability of SQ109, Preliminary efficacy will be assessed by serial Urea Breath Tests during the 14 days of drug administration, and recurrence will be assessed during the 14 days following the last dose of study drug.

Sequella, Inc.

Helicobacter Infections

Disease Attributes

Bacterial Infections

Gram-Negative Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

Gastrointestinal Agents

Dermatologic Agents

Metronidazole

Amoxicillin

Esomeprazole

Clarithromycin

Coal Tar

Antacids

Anti-Ulcer Agents

Proton Pump Inhibitors

Enzyme Inhibitors

esomeprazole and amoxicillin and clarithromycin and metronidazole for 10 days

esomeprazole and amoxicillin for 5 days, followed by esoprazole and clarithromycin and metronidazole for 5 more days

esomeprazole (40 mg daily) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, metronidazole (500 mg, bid) from day 6 to day 10

10-day sequential treatment

esomeprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 10, clarithromycin (500 mg, bid) from day 1 to day 10, metronidazole (500 mg, bid) from day 1 to day 10

10-day concomitant therapy

Ching-Kuan Liu, MD, PhD

David Y Graham, MD

Antone R Opekun, PA-C

Deng-Chyang Wu, MD PhD

Helicobacter pylori is a bacteria that infects the lining of the stomach and is associated with ulcers. Helicobacter pylori may also increase the long-term risk of developing certain forms of gastric cancer. Curing this infection generally requires that patients take 2 or more antibiotic medications and a stomach acid suppressing medication for about two weeks. Current treatments do not always cure the infection and a new treatment is being tested in this study. The drugs involved in the new 4 drug treatment have been widely used for treatment of this infection. It remains unknown what is the best and most cost effective way to give them. This study will compare three different ways of using these drugs.

Subjects must have active Helicobacter pylori infection in order to participate in this study.

The purpose of this study is to compare different methods of giving combination drug therapy for treating Helicobacter pylori infection of the stomach. The entire study will last less than 2 years. Each subject will be participating in the study for approximately 60 days.

A total of 360 subjects will be asked to participate in this study.

Before participating in this study, subject's must have undergone to confirm the presence and to assess the susceptibility of Helicobacter pylori. Qualified subjects will receive 4 drugs which are to be taken as part of the study treatment: an acid suppressing drug (name), amoxicillin, clarithromycin and metronidazole. The doses are 1 grams of amoxicillin, 40 mg of esomeprazole (Nexium), 500 mg of metronidazole and 250 mg of clarithromycin. Each drug will be given twice a day to be taken twice a day with the morning and evening meals. Subjects will receive one of three different combinations. The choice of which will be randomly chosen by the use of a computer program. The regimes are: all 4 drugs daily for 5 days, all 4 drugs daily for 10 days, and two drugs (esomeprazole and amoxicillin) for 5 days then all for drugs for 5 additional days.

Subjects will be asked to return within 4 days after completion of the treatment to evaluate how they did with the drugs. They will be asked bring back all unused medication and the bottles or containers that the medicine was packaged in. Your medication use and tolerance to the study drugs will be assessed. The treatment portion of the study will be complete at this point.

Evaluation of the effect of the treatment will take place 4-6 weeks after the end of therapy. Subjects will come back to the study site and will have a UBT or repeat endoscopy, if clinically indicated to verify that the Helicobacter pylori has been cured. Subjects will be asked not to take antibiotics or any other drugs that may affect the outcome of the breath test used to confirm that the treatment was successful.

Comparison of Sequential or Concomitant Therapy for Helicobacter Pylori Infection

Sequential Versus Concomitant Therapy for Helicobacter Pylori Infection

Evaluate eradication outcome by endoscopy urease test and histology or urea breath test

Good drug compliance is defined as taking equal to or more than 80% of eradication medicines

Baylor College of Medicine

Kaohsiung Veterans General Hospital.

Professor

esoprazole (40 mg, bid), amoxicillin (1 g, bid), clarithromycin (500 mg, bid) and metronidazole (500 mg, bid) for 10 days

Concomitant Therapy (A)

esoprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, and metronidazole (500 mg, bid) from day 6 to day 10

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
Evaluation of SQ109 Plus PPI in Urea Breath Test-Positive Volunteers	NCT01252108	Helicobacter Py...	SQ109	18 Years - 45 Years	Sequella, Inc.
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
Comparison of Sequential or Concomitant Therapy for Helicobacter Pylori Infection	NCT00656968	Helicobacter In...	10-day sequenti... 10-day concomit...	18 Years - 75 Years	Kaohsiung Veterans General Hospital.
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
Evaluation of SQ109 Plus PPI in Urea Breath Test-Positive Volunteers	NCT01252108	Helicobacter Py...	SQ109	18 Years - 45 Years	Sequella, Inc.
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 peptic ulcer disease