Helicobacter Pylori and Proton Pump Inhibitor

NCT02449941 | Completed

• 1 other identifier: 2014-0341
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to know the distribution of HP in stomach before use of PPI, during use of PPI, and after stop of PPI.

Conditions

Helicobacter Infections

Keywords

Stomach Neoplasms; proton pump inhibitor; endoscopic submucosal dissection; Helicobacter pylori; Gastritis, Atrophic

Outcome Measures

Primary Outcomes (1)

• Analysis the change of Helicobacter pylori distribution according to the use of proton pump inhibitor

  Change in the distribution of Helicobacter Pylori(HP) at 4 months.

Secondary Outcomes (1)

• Analysis the change of HP distribution according to the use of PPI in atrophic change of stomach

  Change in the distribution of Helicobacter Pylori(HP) at 4 months.

Study Arms (1)

Helicobacter pylori(HP) positive

Participants who are diagnosed with Helicobacter Pylori infection through ESD(endoscopic submucosal dissection) will be treated with PPI (proton pump inhibitor).

Drug: PPI (proton pump inhibitor)

Interventions

PPI (proton pump inhibitor) DRUG

1. Pre ESD (endoscopic submucosal dissection) * Assessment atrophy and metaplasia in stomach, Check Helicobacter pylori * Use of PPI for 2 months 2. Post ESD 1 (After 2 months) * Assess the distribution of helicobacter pylori after using PPI. * Stop of PPI 3. Post ESD 2 (After 4 months) * Assess the distribution of helicobacter pylori after stop of PPI.

Also known as: pantoprazole, lansoprazole, dexlansoprazole, rabeprazole

Helicobacter pylori(HP) positive

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sample size will be determined based on the analysis the distribution rate of HP at first 30 patients.

You may qualify if:

• Patients who are indicated to endoscopic resection due to gastric neoplasm
• Aged between 19 to 65 years
• Informed consent

You may not qualify if:

• Previous history of HP eradication
• Previous history of PPI use within 6 months
• No HP infection

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu, 138-736, South Korea

Location

Related Publications (1)

• Gong EJ, Kim DH, Ahn JY, Na HK, Jung KW, Lee JH, Choi KD, Song HJ, Lee GH, Jung HY, Park Y, Kim MJ. Effects of Proton Pump Inhibitor on the Distribution of Helicobacter pylori and Associated Gastritis in Patients with Gastric Atrophy. Digestion. 2020;101(3):279-286. doi: 10.1159/000499424. Epub 2019 May 8.

  PMID: 31067538 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

endoscopic biopsy

MeSH Terms

Conditions

Helicobacter Infections; Stomach Neoplasms; Gastritis, Atrophic

Interventions

Proton Pump Inhibitors; Pantoprazole; Lansoprazole; Dexlansoprazole; Rabeprazole

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastritis; Gastroenteritis

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ji Yong Ahn, Professor

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 14, 2015
• First Posted: May 21, 2015
• Study Start: March 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 6, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)