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Age: 18Years - 75Years
All Genders
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ID07250308

A Prospective Observational Study on the Correlation Between Pathologically Confirmed Chronic Atrophic Gastritis and Functional Dyspepsia Symptoms

Led by The Third Affiliated hospital of Zhejiang Chinese Medical University · Updated on 2025-11-26

315

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Dyspepsia is a widespread digestive condition affecting around 21.8% of people worldwide, with most cases diagnosed as functional dyspepsia (FD) and a smaller portion linked to chronic atrophic gastritis (CAG), a precancerous stomach condition. This study investigates the differences in dyspeptic symptoms between patients with confirmed CAG and those without CAG, aiming to clarify the relationship between these conditions and improve clinical understanding. It also explores how factors like Helicobacter pylori infection, diet, sleep quality, and psychological health influence symptoms, alongside a blood metabolomics analysis to find potential biomarkers. This observational study will enroll 258 to 315 adult patients aged 18 to 75 who have had recent endoscopic findings suggesting atrophic gastritis. Participants will undergo a standardized five-point gastric biopsy to confirm CAG status and be grouped accordingly. At enrollment, participants will complete questionnaires assessing symptoms, infection status, diet, sleep, anxiety, depression, and stress. A subset will provide fasting blood samples for detailed metabolite profiling. The study involves a single baseline assessment without long-term follow-up. Participants will provide detailed medical and lifestyle information, complete symptom and psychological questionnaires, and have their H. pylori infection status tested. Researchers will use the Gastrointestinal Symptom Scale to measure key dyspeptic symptoms and analyze differences between groups. The study also includes metabolomics to uncover metabolic pathways linked to symptoms. This research is expected to last 24 months, covering preparation, recruitment, data collection, and analysis, aiming to enhance symptom management and guide future personalized treatments.

CONDITIONS

Brief Title

Correlation Study of Atrophic Gastritis and Dyspepsia Symptoms

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-75 years
  • Recent gastroscopic examination (within 1 year) suggesting chronic atrophic gastritis
  • Underwent standardized pathological examination with 5-point gastric mucosa biopsy according to the "Updated Sydney System"
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Gastric cancer or suspected malignant lesions
  • Significant other gastrointestinal diseases such as ulcers or Barrett's esophagus
  • Autoimmune gastritis
  • Unable to complete questionnaire survey

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Within 1 year prior to enrollment

Participants undergo standardized gastric mucosal biopsy and pathological examination to confirm chronic atrophic gastritis status.

1 visit (in-person)

Observational Assessment

Duration - Single day

Participants complete a single baseline assessment including symptom questionnaires, serological tests, dietary and psychological evaluations, and for some, fasting blood samples for metabolomics analysis.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

The Third Affiliated Hospital of Zhejiang Chinese Medicinal University

Hangzhou, Zhejiang, China, 310053

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Research Team

Y

Yi Liang, PhD

S

Siyi 郑思懿 Zheng, Master's

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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