The Effact of Helicobacter Hylori Eradication on the Development of Gastric Mucosa Pathology

Helicobacter Gastritis Clinical Trial

Official title:

he Effact of Helicobacter Hylori Eradication on the Development of Gastric Mucosa Pathology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04029441
• Other study ID #: 2018SDU-QILU-G115
• Status: Recruiting
• Start date: September 1, 2018
• Est. completion date: September 30, 2021

Study information

• Verified date: July 2019
• Source: Shandong University
• Contact: Xiuli H Zuo, MD,PhD
• Phone: 15588818685
• Email: zuoxiuli[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Subjects who are included will recieve Hp eradication therapy based on antimicrobial susceptibility test. After the therapy, the subjects will be divided into two groups, the successful group and the failure group. And then they wiil be followed up to observe the development of the gastric mucosa pathology.

Description:

Subjects who are included will recieve Hp eradication therapy based on antimicrobial susceptibility test. After the therapy, the subjects will be divided into two groups, the successful group and the failure group. The subjects who fail to eradicate the Hp after initial treatment and rescue treatment will go into the failure group. Otherwhile, they will go to the successful group.And then they wiil be followed up to observe the development of the gastric mucosa pathology. For mild atrophy gastritis, non- intestinal metaplasial gastritis, follow-up is performed every 2-3 years.For severe atrophy gastritis, intestinal metaplasial gastritis, follow-up is performed every 1-2 years. For patients wth high-grade intraepithelial neoplasia, they can be included 3 months after the endoscopic treatment, and the follow up will be performed at 6, 12 months after the treatment and then the follow up will be carried out every 1 year. For non-atrophic gastritis, no follow-up will be performed. All included patients will recieve a follow-up at the endpoint of 5 years. The follow-up includes endoscopy examination and serum test of PG I,PG II and gastrin 17.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients, aged between 18 and 70 years old, with positive H. pylori infection that was not eradicated by previous therapies are included. The H. pylori infection is confirmed by the positive rapid urease test or 13C-breath test.

Exclusion Criteria:

• Patients with significant underlying disease including liver, cardiac, pulmonary, and renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, patients with peptic ulcer, the use of PPI, NSAID or antibiotics during the 4 weeks prior to enrolment, and previous history of allergic reactions to any of the medications used in this protocol. Patients previously treated with H. pylori eradication regimens or those unwilling to participate in the study were also excluded.

Related Conditions & MeSH terms

• Gastritis
• Helicobacter Gastritis

Intervention

Other:
• the eradication Hp
the eradication of Hp based on antimicrobial susceptibility test

Locations

Country	Name	City	State
China	Qilu hosipital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the pathologic status of mucosa	the development or change pathologic status of mucosa	5 years
Secondary	PG I	the serum level of PG I	5 years
Secondary	PG II	the serum level of PG II	5 years
Secondary	gastrin 17	the serum level of gastrin 17	5 years