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NCT Number: NCT06707701

Correlation Among Various OLGA and OLGIM Stages, Digestive Symptom Scores, and Acupuncture Treatment in Patients with Chronic Atrophic Gastritis

Brief Summary Template for the Study:

The goal of this observational study is to examine the relationship between digestive symptom scores, serum pepsinogen indices, and histopathological OLGA and OLGIM systematic staging of the gastric mucosa in patients with chronic atrophic gastritis(CAG), aiming to determine the degree of correlation between clinical manifestations, non-invasive laboratory tests, and the gold standard of diagnostic histopathology.To evaluate the comprehensive therapy, readiness and acceptance of acupuncture, utilization rates of various acupuncture therapies, self-assessed efficacy of acupuncture, and endoscopic histopathological alterations in patients with CAG.According to the aforementioned study, it is anticipated to enhance the optimization of acupuncture clinical research protocols for chronic atrophic gastritis, improve treatment efficacy, and offer more effective and rational therapy alternatives for patients.The main question it aims to answer is:

To determine if the outcomes of combined serologic testing of symptoms in patients with CAG can serve as a method for monitoring disease development and if long-term follow-up can be supported?

A group of participants with recorded GI symptom scores and blood pepsinogen levels will respond to online survey questions regarding the severity of their chronic atrophic gastritis progression over the course of 1 year.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

This study is a multicenter cross-sectional pilot survey

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fulfill the diagnostic criteria for chronic atrophic gastritis;
  • Individuals aged 18 to 75 years, irrespective of gender;
  • Capable of comprehending and consenting to participate in this study by signing the informed consent form.

Exclusion criteria

  • Autoimmune gastritis (type A chronic atrophic gastritis);
  • Patients diagnosed with Gastroesophageal Reflux Disease (GERD) by endoscopy or other examinations or patients diagnosed with high-grade intraepithelial neoplasia by upper gastrointestinal endoscopy and gastric mucosal biopsy pathology;
  • Patients with confirmed or unable to exclude malignant tumors, especially esophageal and gastric cancers; patients with other upper gastrointestinal tract pathologies such as peptic ulcer or Barrett's esophagus;
  • Those who cannot complete the questionnaire due to unconsciousness, inability to communicate normally or other reasons; those with incomplete information.

Treatment and study plan

Acupuncture

Other

Whether or not a patient has been treated with acupuncture will be one of the exposure factors of interest in the study

Primary outcomes

  1. Correlation between gastrointestinal symptom scores combined with serum pepsinogen indexes and histopathologic OLGA and OLGIM systematic staging of gastric mucosa in patients with CAG

    Time frame: Gastroscopy and pathology reports within one year, serology and symptom assessment within one week of participant enrollment

    The investigators gathered clinical data on the overall condition, occupation, personal history, family history, H. pylori infection, gastrointestinal symptom scores, serum pepsinogen index, gastroscopy reports, pathological findings, and other biological characteristics of CAG patients, along with data pertaining to acupuncture treatment. The investigators then analyzed the correlation between the gastrointestinal symptom scores, the serum pepsinogen index, and the gastric mucosal histopathology OLGA and OLGIM. The investigators examined the relationship between gastrointestinal symptom scores, serum pepsinogen levels, and the histopathological OLGA and OLGIM stages of gastric mucosa to determine the correlation between clinical manifestations, non-invasive laboratory tests, and the definitive diagnostic standard of histopathology, thereby offering support for clinicians.

Secondary outcomes

  1. Correlation coefficients of relevant exposure factors (including acupuncture treatment status) with OLGA, OLGIM pathologic stage and GI symptom score, respectively

    Time frame: Patient's treatment to date after diagnosis of chronic atrophic gastritis, and whether participant has received acupuncture in the last 3 months

    With the goal of further optimizing the clinical research protocols of acupuncture for CAG, improving the therapeutic effects, and offering a more effective and affordable treatment option for patients with chronic atrophic gastritis, the investigators examined the overall treatment of CAG patients, willingness and acceptance of acupuncture treatment, application rate of various acupuncture therapies, self-perceived acupuncture efficacy, and endoscopic histopathological changes.

Study contacts

Contact information is provided by the study sponsor or research team.

Yi Liang, Doctor

CONTACT

[email protected]

+86 571 86633328

Sponsors and collaborators

Lead sponsor

Yi Liang

Other

Collaborators

  • Zhejiang University of Science and Technology

Registry information

Official study title

Correlation Among Various OLGA and OLGIM Stages, Digestive Symptom Scores, and Acupuncture Treatment in Patients with Chronic Atrophic Gastritis:a Multicenter Cross-sectional Pilot Survey

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 27, 2024
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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