JMIR Publications

ABSTRACT

Background:

Chronic atrophic gastritis (CAG) is widely recognized as one of the precancerous lesions of gastric cancer. Helicobacter pylori (HP) is one of the important risk factors for CAG and gastric cancer. However, a large proportion of the CAG patients cannot avoid developing gastric cancer even after eradicating HP. It is necessary to find a safe and effective treatment to suppress this "inflammation-cancer" progression.

Objective:

The Qi-Lian-Xiao-Pi prescription (QLXP), a traditional Chinese medicine (TCM), has been reported to be effective in the treatment of CAG. However, the evidence is subject to methodological limitations. Therefore, a parallel-arm, randomized controlled, multicentered, placebo-controlled, and single-blinded trial was designed to evaluate the efficacy, safety, and mechanism of QLXP in the treatment of patients with CAG after HP eradication.

Methods:

The QLXP in the treatment of CAG after HP eradication clinical trial is designed as a rigorous multicenter, randomized, double-blind, placebo-controlled study. The sample size is 110 cases, with 55 participants in the intervention and control groups, respectively. The intervention group receives the QLXP treatment, while the control group takes the QLXP placebo. The medication lasts for 24 weeks, and the follow-up lasts for 24 weeks. We will employ blinded histopathological assessments utilizing the OLGA (Operative link on gastritis assessment) and OLGIM (gastric intestinal metaplasia assessment) scoring systems as primary efficacy indicators. The improvement rate of gastric mucosal gland atrophy and intestinal metaplasia (IM), as well as the TCM syndrome scoring, are used as secondary efficacy indicators. The safety assessment includes vital signs, adverse events, blood routine, urine routine, stool routine and occult blood, liver function tests, kidney function tests, and electrocardiogram. In addition, the gastric mucosal DNA methylation detection and the metagenomic sequencing of digestive tract microbiota, including saliva, tongue coating, stomach, and intestinal microbiota, will be collected to further explore the mechanism in the process of QLXP in improving CAG.

Results:

The funding began in November 2023. The study was officially initiated on April 20, 2025, with the enrollment of the first participant. The final study results, including efficacy outcomes, safety profiles, and mechanistic insights, are expected to be released in October 2026 after comprehensive data analysis and verification.

Conclusions:

We anticipate that patients with CAG will be improved from QLXP by regulating gastric mucosal DNA methylation and digestive tract microbiota. This study represents a pioneering prospective trial in traditional Chinese medicine aimed at observing and treating CAG through direct restoration of digestive tract microbiota homeostasis and regulation of DNA methylation. If successful, this clinical trial will significantly contribute to the development of therapeutic strategies for CAG and provide valuable insights into drug development. Clinical Trial: Trial registration number This trial is registered on Chinese Clinical Trials Registry (ChiCTR2400084357) on May 15, 2024 (http://www.chictr.org.cn).