Efficacy, Safety, and Mechanism of the Qi-Lian-Xiao-Pi Prescription (WW-1) for Chronic Atrophic Gastritis After Helicobacter Pylori Eradication: Protocol for a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.

Authors

Wei Bai, Guodong Huang, Xianjun Rao, Hao Li, Tingting Zhou, Yang Yang, Wei Wei

Published in

JMIR research protocols. Volume 15. Pages e90965. Jul 08, 2026. Epub Jul 08, 2026.

Abstract

Chronic atrophic gastritis (CAG) is widely recognized as one of the precancerous lesions of gastric cancer. Helicobacter pylori is one of the important risk factors for CAG and gastric cancer. However, a large proportion of patients with CAG cannot avoid developing gastric cancer even after eradicating H pylori. It is necessary to find a safe and effective treatment to suppress this "inflammation-cancer" progression. The Qi-Lian-Xiao-Pi prescription (WW-1), a traditional Chinese medicine (TCM), has been reported to be effective in the treatment of CAG. However, the evidence is subject to methodological limitations.
This study aimed to evaluate the efficacy, safety, and mechanism of the WW-1 in patients with CAG following successful H pylori eradication.
This study is a rigorous parallel-arm, randomized, placebo-controlled, multicenter, double-blinded trial. A total of 110 eligible participants with a confirmed diagnosis of CAG after H pylori eradication are being enrolled and randomly assigned in a 1:1 ratio to either the intervention group (WW-1) or the control group (WW-1 placebo). Key eligibility criteria include confirmed CAG by histopathology, documented successful H pylori eradication, and compliance with predefined inclusion and exclusion criteria. The treatment duration is 24 weeks. Blinded histopathological assessments using the Operative Link on Gastritis Assessment and Operative Link on Gastric Intestinal Metaplasia Assessment staging systems will serve as primary outcomes. Secondary outcomes include improvement rates of gastric mucosal gland atrophy and intestinal metaplasia, as well as TCM syndrome scores. Safety will be assessed through monitoring vital signs, adverse events, blood, urine, and stool tests, liver and kidney function, and electrocardiography. Additionally, gastric mucosal DNA methylation and metagenomic sequencing of digestive tract microbiota (including saliva, tongue coating, gastric, and intestinal samples) will be analyzed to explore potential mechanisms of WW-1.
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.
This study is designed to determine whether WW-1 can improve CAG by modulating gastric mucosal DNA methylation and the digestive tract microbiota. It represents a prospective clinical trial in TCM that aims to evaluate therapeutic effects on CAG through the regulation of microbiota homeostasis and epigenetic mechanisms. The findings of this study are expected to provide evidence regarding the efficacy and safety of WW-1 and contribute to the development of therapeutic strategies and future drug research for CAG.
DERR1-10.2196/90965.

PMID:
42418263
Bibliographic data and abstract were imported from PubMed on 08 Jul 2026.

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