Weifuchun tablets versus folic acid to reverse gastric intestinal metaplasia
Official title: Efficacy and Safety of Weifuchun Tablet in Reversing Gastric Intestinal Metaplasia: A Multi-center, Open-label, Randomized Controlled Trial
Run by Xijing Hospital of Digestive Diseases · NCT06610266 · Data updated 2026-11-12
This trial tries to see if taking Weifuchun tablets daily for six months can reverse gastric intestinal metaplasia in adults without Helicobacter pylori compared with daily folic acid.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Xijing Hospital of Digestive Diseases Academic / other |
| Locations | 9 sites (Ankang and 8 other locations) |
| Status | Recruiting |
| Started | February 28, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | August 6, 2026 |
| Trial ID | NCT06610266 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–75 with OLGIM stage II–IV gastric intestinal metaplasia who are Helicobacter pylori–negative (including previously successfully eradicated) and able to take daily medication and attend monthly follow-up visits are the intended participants.
✕Probably not a fit
Patients with recent H. pylori infection, prior stomach surgery or malignancy, severe heart/renal/liver disease, pregnancy or breastfeeding, regular NSAID or statin use, substance or alcohol abuse within one year, severe mental illness, or who refuse drug treatment are excluded and unlikely to receive benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 4 interventional study enrolls adults aged 18–75 with OLGIM stage II–IV gastric intestinal metaplasia who are Helicobacter pylori–negative. Participants will take either Weifuchun tablets or folic acid every day for six months and visit the clinic about once every four weeks for exams and safety checks. Eligibility requires recent endoscopic and histopathologic confirmation of OLGIM stage II–IV, and investigators will compare changes in intestinal metaplasia and record any adverse events. Folic acid is used as the comparator in line with Chinese consensus recommendations for managing gastric precancerous conditions.
Why it matters
Potential benefit: If successful, Weifuchun could provide a non‑surgical treatment option to reduce or reverse precancerous gastric changes in H. pylori–negative patients.
How similar studies have gone: Some small trials and observational studies, largely from China, have suggested Weifuchun may improve chronic atrophic gastritis and related precancerous lesions, but high‑quality randomized evidence remains limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients aged from 18 to 75 years old. * patients with OLGIM stage Ⅱ-Ⅳ diagnosed by upper gastrointestinal endoscopy and histopathological examination within the last 3 months. * patients without Helicobacter pylori infection, including patients who had successful Helicobacter pylori eradication before enrollment. Exclusion Criteria: * a history of regular use (defined as at least once per week) of non-steroidal anti-inflammatory drugs (NSAIDs) and/or statins. * a history of stomach surgery (including endoscopic submucosal dissection and endoscopic mucosal resection) or previously diagnosed malignant tumor. * a history of heart failure, renal failure, liver cirrhosis or chronic hepatic failure; patients with contraindications or allergies to the drugs in this study. * breastfeeding or pregnancy. * a history of substance abuse or alcohol abuse within the past one year. * patients with severe mental illness. * refusal to undergo drug treatment. * refusal to sign informed consent.
Where it's running
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Ankang Central Hospital
Ankang, China Recruiting -
Tongchuan People's Hospital
Tongchuan, China Recruiting -
Weinan Central Hospital
Weinan, China Recruiting -
The 986th Hospital of Air Force Medical University
Xi'an, China Recruiting -
Xijing hospital
Xi'an, China Recruiting -
Xi'an Central Hospital
Xi'an, China Recruiting
Show 3 more locations
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Xi'an Honghui Hospital
Xi'an, China Recruiting -
Xunyang People's Hospital
Xuchang, China Recruiting -
Affiliated Hospital of Yan'an University
Yanan, China Recruiting
Study contacts
- Study coordinator: Yongquan Shi
- Email: shiyquan@fmmu.edu.cn
- Phone: 0086 + 02984771515
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.