Clinical trial NCT04029441: The Effact of Helicobacter Hylori Eradication on the Development of Gastric Mucosa Pathology
Official title: he Effact of Helicobacter Hylori Eradication on the Development of Gastric Mucosa Pathology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Helicobacter Gastritis
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients, aged between 18 and 70 years old, with positive H. pylori infection that was not eradicated by previous therapies are included.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the pathologic status of mucosa
timeFrame: 5 years
Secondary outcomes:
measure: PG I
timeFrame: 5 years
measure: PG II
timeFrame: 5 years
measure: gastrin 17
timeFrame: 5 years
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hosipital
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiuli H Zuo
role: STUDY_CHAIR
affiliation: Qilu Hospital of Shandong University
name: Tian H Ma
role: PRINCIPAL_INVESTIGATOR
References: