Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasms

Rare Diseases

Atrophy

Gastrointestinal Diseases

Gastritis, Atrophic

Metaplasia

Precancerous Conditions

Gastritis

Gastroenteritis

Stomach Diseases

Chronic Graft Versus Host Disease

Luis G Carvajal-Carmona, PhD

To establish a prospective cohort of individuals diagnosed with gastric pre-malignant conditions (chronic gastritis, atrophic gastritis, autoimmune gastritis, intestinal metaplasia, intestinal dysplasia) to monitor and study disease progression. The Investigators will like to survey cohort participants for lifestyle behaviors and environmental exposures associated with gastric pre-malignancy and cancer. Analyzing patient biospecimens to identify and characterize host and microbiome biomarkers associated with initiation and progression of gastric pre-malignancies.

Initially, study coordinators will identify prevalent patients diagnosed with gastric pre-malignancy at UC Davis Health in the last five years or receive a list of eligible patients by a GI doctor at UC Davis Health. These individuals will be sent an invitation letter via mail or by physician, to participate in the study and will be provided with a reply slip authorizing contact by the research team. Individuals willing to participate in the study will be then contacted by research coordinators via phone/mail to:

i) Provide information about the study and answer questions (via phone call, video-conference, letter or email),

ii) Answer study questionnaire

iii) Sign study's informed consent to provide saliva, blood, urine and/or stool samples.

iv) Sign a HIPPA form to obtain permission to retrieve archival tumor blocks and pathology reports

Participants will be also asked for permission to regular re-contact and will be asked to inform study coordinators about future endoscopic appointments, where blood, stomach biopsies and stomach juice samples will be obtained. If the participant agrees, permission will be requested for these samples as well.

To recruit incident participants, the research coordinators will review endoscopic schedules and or be provided a list of patients who fit the criteria to identify participants suspected or diagnosed with gastric pre-malignant diseases. Participants will be asked to consent and asked to fill out a short version survey before their endoscopic procedure. Contact information will be collected (Phone, Address, Email) in order to send the full version of the survey later. Participants will be asked if they would like to donate a blood, saliva and urine sample and will be provided with a stool collection kit for home sampling, which will be returned to the research team in a pre-paid padded envelope. At the appointment, participants will also be asked if they would agree to provide tissue and/or gastric juices that will be obtained by their physician during their procedure or any leftover tissue after histological examination. For specimens requiring histological analyses, only once consents and/or HIPPA waivers are received will any leftover specimens be collected for this research study.

All participants (prevalent and incidence) will be contacted once a year to update surveys, clinical and risk factor information, consent and HIPPA waivers.

Data from the study questionnaire will be analyzed regularly using standard epidemiological methods. Biospecimens will be used for multiple omics approaches and results will be published regularly in medical and scientific journals and conferences.

With patient consents, study team will collect saliva, stool, blood and/or gastric biopsy or gastric juices.

A Study of Pre-Malignant Gastric Conditions

The UC Davis Cohort of Pre-Malignant and Malignant GastroIntestinal DisEases (TUMMIE) Study

Review the number of patients with gastric conditions and any progression to advanced pre-neoplasia/malignancy or cancer and identify and characterize host and microbiome biomarkers associated with initiation and progression of gastric pre-malignancies

Review number of patients response rates who donated full/partial biospecimen samples.

University of California, Davis

Stomach Neoplasms

Ulcer

Polyps

Stomach Ulcer

Peptic Ulcer

Duodenal Diseases

Intestinal Diseases

Stomach Cancer

patients were assigned to swallow MCE first, followed by the gastroscopy

Standard gastroscopy

Zhaoshen Li, Prof.

A new Magnetic-controlled Capsule Endoscopy (MCE) was developed by ANKON and got SFDA's approval in China in 2013. It has recently been evaluated to compare the diagnostic accuracy of MCE with that of standard gastroscopy for gastric diseases in 70 patients with encouraging results (In Press). To further testify the diagnostic accuracy of MCE for both the diffuse and focal diseases in stomach, we performed this single-blinded multi-center prospective study compared MCE with gastroscopy in patients with gastric symptoms and indication for upper GI Endoscopy.

Magnetic-controlled Capsule Endoscopy vs. Gastroscopy for Detection of Gastric Diseases

Magnetic-controlled Capsule Endoscopy vs. Gastroscopy for Detection of Gastric Diseases: A Prospective Self-controlled Comparative Multicenter Trial

RenJi Hospital

Nanfang Hospital, Southern Medical University

Chinese PLA General Hospital

General Hospital of Beijing PLA Military Region

Wuhan Union Hospital, China

Shandong Provincial Hospital

Peking Union Medical College Hospital

Changhai Hospital

Director of Gastroenterology Dept.

Infections

Communicable Diseases

Anti-Infective Agents

All Drugs and Chemicals

Gastrointestinal Agents

Amoxicillin

Esomeprazole

Bismuth

Tetracycline

Furazolidone

Anti-Bacterial Agents

Antacids

Anti-Ulcer Agents

Proton Pump Inhibitors

Enzyme Inhibitors

Anti-Infective Agents, Local

Antiprotozoal Agents

Antiparasitic Agents

Monoamine Oxidase Inhibitors

Berberine 500mg three time daily for 14days, amoxicillin 1000 mg, esomeprazole 20 mg, and Bismuth 200mg by mouth, twice daily for 14 days.

Tetracycline 500mg three time daily for 14days，furazolidone 100 mg, esomeprazole 20 mg, and Bismuth 200mg by mouth, twice daily for 14 days.

Berberine-amoxicillin quadruple therapy group: given for 14 days at a dose of berberine 100 mg 3 tablets TID, amoxicillin 500 mg 2 capsules BID ，esomeprazole 20 mg BID, ,and Bismuth 100 mg 2 capsules BID.

Berberine

Berberine-amoxicillin quadruple therapy group: given for 14 days at a dose of Amoxicillin 500 mg 2 capsules BID plus berberine 100 mg 3 tablets TID, esomeprazole 20mg 1tablet BID, and bismuth 100 mg 2 capsules BID

Berberine-amoxicillin quadruple therapy group: given for 14 days at a dose of Esomeprazole 20mg 1 tablet BID plus berberine 100 mg 3 tablets TID,amoxicillin 500 mg 2 capsules BID, and bismuth 100 mg 2 capsules BID

Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of Tetracycline 250mg 2 capsules TID plus furazolidone 100mg 1 tablets BID，esomeprazole 20 mg 1 tablets BID and bismuth 100 mg 2 capsules BID

Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of Tetracycline 250mg 2 capsulesTID plus furazolidone 100mg 1 tablets BID，esomeprazole 20 mg 1 tablets BID and bismuth 100 mg 2 capsules BID

Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of furazolidone 100mg 1 tablets BID plus Tetracycline 250mg 2 capsulesTID，esomeprazole 20 mg 1 tablets BID and bismuth 100 mg 2 capsules BID

Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of esomeprazole 20 mg 1 tablets BID plus Tetracycline 250mg 2 capsules TID, furazolidone 100mg 1 tablets BID， and bismuth 100 mg 2 capsules BID

Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of bismuth 100 mg 2 capsules BID plus Tetracycline 250mg 2 capsules TID ，furazolidone 100mg 1 tablets BID and esomeprazole 20 mg 1 tablets BID

This study aims at evaluating efficacy and safety of berberine- amoxicillin containing quadruple therapy(berberine, amoxicillin, esomeprazole and bismuth) versus tetracycline-furazolidone quadruple therapy (tetracycline, furazolidone, esomeprazole and bismuth) in H. pylori rescue therapy. It is hypothesized that berberine-amoxicillin containing quadruple therapy is non-inferior to tetracycline-furazolidone 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.

Detailed Description:

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 13 and 17.

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 Berberine Plus Amoxicillin Quadruple Therapy Versus Tetracycline Plus Furazolidone Quadruple Therapy

Rescue Therapy for Helicobacter Pylori Eradication: A Randomized and Non-inferiority Trail of Berberine Plus Amoxicillin Quadruple Therapy Versus Tetracycline Plus Furazolidone Quadruple Therapy

The primary end point of this study is H.pylori eradication,established by negative urea breath test，rapid urease test or helicobacter pylori stool antigen test 28 days after the end of treatment.

Evaluation effective rate of symptoms 2 weeks of treatment and 4 weeks after the end of treatment.

Symptom effective rate =（total score before treatment - total score after treatment）/total score before treatment x 100%.

Total score = frequency \* severity.

Frequency score is calculated by all the frequency of heartburn, reflux, abdominal pain, and flatulence.

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.

Xijing Hospital of Digestive Diseases

Professor

Syndrome

Healthy Volunteers with Balanced Constitution(n=10).

Healthy Volunteers with Qi Deficiency Constitution(n=10).

Healthy Volunteers with Damp-heat Constitution(n=10).

Superficial Gastritis with Spleen-qi Deficiency Syndrome(n=10).

Superficial Gastritis with Damp-heat Syndrome(n=10).

Atrophic Gastritis with Spleen-qi Deficiency Syndrome(n=10).

Atrophic Gastritis with Damp-heat Syndrome(n=10).

Gastric Cancer with Spleen-qi Deficiency Syndrome(n=10).

Gastric Cancer with Damp-heat Syndrome(n=10).

Xiaopu Sang

Leiming You

Anlong Xu

Spleen Deficiency Syndrome(SDS)is a widely researched issue, but due to the limitations of the research methods, the scientific mechanism of SDS is biased and not comprehensive. SDS would be researched in this project deeply and systematically with modern life-scientific methods. Based on the previous work, the participants, with SDS, suffering from Qi deficiency syndrome--chronic superficial gastritis--chronic atrophic gastritis--gastric cancer would be included, and the corresponding research would be conducted at the molecular-cell-gastric tissue level, and at the same time, systematical biological database of SDS would be built by systematical biological methods, such as pioneered SPARS sequencing technology created in our research group, proteomics and metabonomics. Under the above work, the investigators would conduct data mining and molecular network analysis, and then verify the key functions. By analyzing the systematical biological features of syndrome and its relationships with constitution and disease, this study would provide a new basis for objective reality of syndrome, and also offer a crucial premise of revealing biological basis for syndrome correctly, which is of important theoretical and practical significance.

System Biology of Spleen Deficiency Syndrome

System Biology Research of Spleen Qi Deficiency Associated "Qi Deficiency Constitution-Disease"

Endoscopic diagnosis standard of chronic gastritis according to Chinese Society of Digestive Endoscopy.

Pathological diagnosis standard of chronic gastritis according to Chinese Society of Gastroenterology.Pathological diagnosis standard of gastric cancer according to Ministry of Health P.R.China

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Pre-Malignant Gastric Conditions	NCT05021029	Intestinal Meta... Chronic Gastrit... Atrophic Gastri... Autoimmune Gast... Intestinal Dysp...		18 Years -	University of California, Davis
Magnetic-controlled Capsule Endoscopy vs. Gastroscopy for Detection of Gastric Diseases	NCT02219529	Gastric Disease... Gastric Ulcer, Gastric Polyps, Early Gastric C... Chronic Gastrit...	MCE Standard gastro...	18 Years - 70 Years	Changhai Hospital
Helicobacter Rescue Therapy With Berberine Plus Amoxicillin Quadruple Therapy Versus Tetracycline Plus Furazolidone Quadruple Therapy	NCT03609892	Gastric Ulcer Chronic Gastrit... Gastric Cancer Helicobacter Py... Gastritis	Berberine Amoxicillin Esomeprazole Bismuth Tetracycline Furazolidone Esomeprazole Bismuth	18 Years - 70 Years	Xijing Hospital of Digestive Diseases
System Biology of Spleen Deficiency Syndrome	NCT02915393	Gastritis, Atro... Gastric Cancer		18 Years - 65 Years	Beijing University of Chinese Medicine
Magnetic-controlled Capsule Endoscopy vs. Gastroscopy for Detection of Gastric Diseases	NCT02219529	Gastric Disease... Gastric Ulcer, Gastric Polyps, Early Gastric C... Chronic Gastrit...	MCE Standard gastro...	18 Years - 70 Years	Changhai Hospital
A Study of Pre-Malignant Gastric Conditions	NCT05021029	Intestinal Meta... Chronic Gastrit... Atrophic Gastri... Autoimmune Gast... Intestinal Dysp...		18 Years -	University of California, Davis
Helicobacter Rescue Therapy With Berberine Plus Amoxicillin Quadruple Therapy Versus Tetracycline Plus Furazolidone Quadruple Therapy	NCT03609892	Gastric Ulcer Chronic Gastrit... Gastric Cancer Helicobacter Py... Gastritis	Berberine Amoxicillin Esomeprazole Bismuth Tetracycline Furazolidone Esomeprazole Bismuth	18 Years - 70 Years	Xijing Hospital of Digestive Diseases

Spots Global Cancer Trial Database for chronic gastritis