NCT06610760 Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia
| NCT ID | NCT06610760 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Yongquan Shi |
| Condition | Gastric Intestinal Metaplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 196 participants |
| Start Date | 2024-11-12 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 196 participants in total. It began in 2024-11-12 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to investigate the efficacy of ursodeoxycholic acid in treating gastric intestinal metaplasia in Helicobacter pylori-negative adults. It will also learn about the safety of ursodeoxycholic acid. The main questions it aims to answer are: Does ursodeoxycholic acid promote the regression of IM in individuals without Helicobacter pylori infection? What medical problems do participants experience when taking ursodeoxycholic acid? Researchers will compare ursodeoxycholic acid to a placebo (a look-alike substance that contains no drug) to see if ursodeoxycholic acid is effective in treating gastric intestinal metaplasia. Participants will: Take ursodeoxycholic acid or a placebo every day for 6 months. Visit the clinic once every 4 weeks for checkups and tests.
Eligibility 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.
Contact & Investigator
Yongquan Shi, PhD
STUDY CHAIR
Air Force Military Medical University, China
Frequently Asked Questions
Who can join the NCT06610760 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Gastric Intestinal Metaplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06610760 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06610760 currently recruiting?
Yes, NCT06610760 is actively recruiting participants. Contact the research team at shiyquan@fmmu.edu.cn for enrollment information.
Where is the NCT06610760 trial being conducted?
This trial is being conducted at Pingdingshan, China, Ankang, China, Hanzhong, China, Shangluo, China and 2 additional locations.
Who is sponsoring the NCT06610760 clinical trial?
NCT06610760 is sponsored by Yongquan Shi. The principal investigator is Yongquan Shi, PhD at Air Force Military Medical University, China. The trial plans to enroll 196 participants.