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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04029441
Enrollment
1200
Registered
2019-07-23
Start date
2018-09-01
Completion date
2021-09-30
Last updated
2019-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Gastritis

Brief 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.

Detailed 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.

Interventions

OTHERthe eradication Hp

the eradication of Hp based on antimicrobial susceptibility test

Sponsors

Shandong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
the pathologic status of mucosa5 yearsthe development or change pathologic status of mucosa

Secondary

MeasureTime frameDescription
PG I5 yearsthe serum level of PG I
PG II5 yearsthe serum level of PG II
gastrin 175 yearsthe serum level of gastrin 17

Countries

China

Contacts

Primary ContactXiuli H Zuo, MD,PhD
zuoxiuli@sdu.edu.cn15588818685
Backup ContactTian H Ma, MD
matian1002@163.com18769781098

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026