Correlation Study of Atrophic Gastritis and Dyspepsia Symptoms

NCT07250308 | Recruiting

• 1 other identifier: 20250901102807691
• Study Type: observational
• Target: 315
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Dyspepsia is a common gastrointestinal complaint globally, affecting approximately 21.8% of the population. Among patients presenting with dyspeptic symptoms, over 80% are diagnosed with functional dyspepsia (FD), while approximately 16% are found to have chronic atrophic gastritis (CAG). CAG represents an important precancerous condition in the gastric cancer cascade, yet the relationship between pathologically confirmed CAG and dyspeptic symptoms remains poorly understood. The significant symptom overlap between CAG and FD creates diagnostic challenges in clinical practice. Study Objectives: The primary objective is to determine whether there are significant differences in the prevalence and severity of dyspeptic symptoms (including epigastric pain, burning sensation, early satiety, and postprandial fullness) between patients with pathologically confirmed CAG and those without CAG (non-CAG group) among individuals who present with endoscopic features suggestive of atrophic gastritis. Secondary objectives include: (1) analyzing the independent effects of various covariates (Helicobacter pylori infection, dietary habits, sleep quality, psychological factors) on dyspeptic symptoms; (2) developing a symptom-based predictive model for pathological CAG; and (3) conducting exploratory serum metabolomics analysis to identify potential biomarkers and metabolic pathways associated with FD symptoms. Study Design: This is a single-center, prospective, observational study conducted at the Third Affiliated Hospital of Zhejiang Chinese Medical University. The study will enroll approximately 258-315 adult patients (aged 18-75 years) who undergo endoscopy showing features suggestive of CAG within the past year. All participants will undergo standardized 5-point gastric mucosal biopsy according to the Updated Sydney System. Based on histopathological results, patients will be classified into pathological CAG group (presence of gastric mucosal atrophy) or non-CAG group (absence of atrophy). The study aims to recruit at least 80 pathologically confirmed non-CAG patients for comparison. Study Procedures: After obtaining informed consent, all enrolled patients will complete a comprehensive assessment at baseline including: demographic information, medical history, endoscopy and pathology results, Gastrointestinal Symptom Scale (GOSS) questionnaire using a 7-point Likert scale, H. pylori infection status (serology), dietary habits assessment, Pittsburgh Sleep Quality Index (PSQI), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), and perceived stress evaluation. A subset of participants will provide fasting blood samples for non-targeted metabolomics analysis using liquid chromatography-mass spectrometry (LC-MS) to identify metabolites related to amino acids, organic acids, lipids, and neurotransmitter precursors. This is a non-interventional study with all data and sample collection completed at enrollment without long-term follow-up. Primary Outcome: The primary outcome is the difference between pathological CAG and non-CAG groups in the prevalence and severity of dyspeptic symptoms, particularly cardinal FD symptoms (epigastric pain, burning, early satiety, postprandial fullness), assessed using the GOSS scale. A symptom score ≥4 on any cardinal symptom will define the presence of clinically significant FD symptoms. Expected Duration: The study is expected to last 24 months, including preparation, patient recruitment with data collection, and final statistical analysis and reporting phases. Significance: This study will provide evidence-based insights into the relationship between pathologically confirmed CAG and dyspeptic symptoms, potentially improving symptom management strategies and patient counseling. The metabolomics component may reveal novel biomarkers and pathways underlying symptom generation, laying groundwork for future mechanistic studies and personalized therapeutic approaches. Results will inform clinical practice and serve as preliminary data for larger-scale investigations.

Conditions

Functional Dyspepsia; Chronic Atrophic Gastritis (CAG)

Keywords

Serumomics; symptom

Outcome Measures

Primary Outcomes (1)

• Difference in Incidence and Severity of Dyspepsia Symptoms

  Comparison of the incidence and severity of typical functional dyspepsia symptoms (epigastric pain, burning sensation, early satiety, postprandial fullness) between pathologically confirmed CAG and non-CAG groups

  At enrollment (baseline)

Secondary Outcomes (14)

• Independent Effect of Helicobacter pylori Infection on Dyspepsia Symptom Severity

  At enrollment (baseline)

• Independent Effect of Sleep Quality on Dyspepsia Symptom Severity

  At enrollment (baseline)

• Independent Effect of Anxiety on Dyspepsia Symptom Severity

  At enrollment (baseline)

• Independent Effect of Depression on Dyspepsia Symptom Severity

  At enrollment (baseline)

• Independent Effect of Perceived Stress on Dyspepsia Symptom Severity

  At enrollment (baseline)

Study Arms (2)

Pathologically Confirmed Chronic Atrophic Gastritis (CAG) Group

Pathologically Confirmed Chronic Atrophic Gastritis (CAG) Group

Non-CAG Group

Patients with endoscopic findings of CAG but without definite atrophy on pathological examination.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (aged 18-75 years) with endoscopic findings suggestive of chronic atrophic gastritis within the past 12 months at the Third Affiliated Hospital of Zhejiang Chinese Medical University. Target enrollment: 258-315 patients to ensure at least 80 pathologically confirmed non-CAG cases. Eligible patients undergo endoscopy for dyspeptic symptoms, surveillance, or upper abdominal discomfort. All undergo standardized 5-point gastric biopsy per Updated Sydney System for histopathological classification into CAG or non-CAG groups. Both symptomatic and asymptomatic patients are eligible; no H. pylori status restrictions. Exclusions: organic GI diseases (peptic ulcer, gastric cancer, IBD), autoimmune gastritis, severe systemic diseases, inability to consent. Consecutive recruitment from routine clinical practice ensures representative sampling.

You may qualify if:

• Age 18-75 years
• Recent gastroscopic examination (within 1 year) suggesting chronic atrophic gastritis
• Underwent standardized pathological examination (5-point gastric mucosa biopsy according to the "Updated Sydney System" including antrum, body, and angle)
• Signed informed consent

You may not qualify if:

• Gastric cancer or suspected malignant lesions
• Concomitant significant other gastrointestinal diseases (e.g., ulcer, Barrett's esophagus, etc.)
• Autoimmune gastritis
• Unable to complete questionnaire survey

Sponsors & Collaborators

• The Third Affiliated hospital of Zhejiang Chinese Medical University: lead

Study Sites (1)

The Third Affiliated Hospital of Zhejiang Chinese Medicinal University

Hangzhou, Zhejiang, 310053, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum samples for metabolomics analysis

MeSH Terms

Conditions

Gastritis, Atrophic

Condition Hierarchy (Ancestors)

Gastritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Officials

• Yi Liang, PhD

  The Third Affiliated Hospital of Zhejiang Chinese Medicial University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Liang, PhD

CONTACT

+86-571-86633328; liangyiwww@126.com

Siyi 郑思懿 Zheng, Master's

CONTACT

15990088547; 1041073233@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 26, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)