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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The ursodeoxycholic acid group | Experimental | Patients in the ursodeoxycholic acid group will receive oral ursodeoxycholic acid at a dosage of 250 mg three times daily for 6 months. |
|
| The placebo group | Placebo Comparator | Patients in the placebo group will receive oral placebo at a dosage of 250 mg three times daily for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ursodeoxycholic Acid | Drug | Subjects will be instructed to take one capsule (250mg) of ursodeoxycholic acid three times daily, and visit the hospital every 4 weeks for evaluation of the subjective symptoms and to receive a new supply of medication. |
| Measure | Description | Time Frame |
|---|---|---|
| The regression rate of gastric intestinal metaplasia based on OLGIM stage in different groups. | Regression was defined as a OLGIM stage decreased at least one grade. | From enrollment to the end of treatment at 6 months |
| The progression rate of gastric intestinal metaplasia based on OLGIM stage in different groups. | Progression was defined as a OLGIM stage increased at least one grade. | From enrollment to the end of treatment at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The regression rate of gastric atrophy based on OLGA stage in different groups. | Regression was defined as a OLGA stage decreased at least one grade. | From enrollment to the end of treatment at 6 months |
| The progression rate of gastric atrophy based on OLGA stage in different groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongquan Shi | Contact | 0086 + 02984771515 | shiyquan@fmmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yongquan Shi, PhD | Air Force Military Medical University, China | Study Chair |
| Xinzhao Wang | 989 Hospital of PLA Joint Logistics Support Force | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 989 Hospital of PLA Joint Logistics Support Force | Recruiting | Pingdingshan | Henan | China |
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| ID | Term |
|---|---|
| D014580 | Ursodeoxycholic Acid |
| ID | Term |
|---|---|
| D003840 | Deoxycholic Acid |
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
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| Placebo | Drug | Subjects will be instructed to take one capsule (250mg) of placebo three times daily, and visit the hospital every 4 weeks for evaluation of the subjective symptoms and to receive a new supply of medication. |
|
Progression was defined as a OLGA stage increased at least one grade. |
| From enrollment to the end of treatment at 6 months |
| Kun Zhuang |
| Xi'an Central Hospital |
| Principal Investigator |
| Zhufang Ma | Hanzhong 3201 Hospital | Principal Investigator |
| Yuan Gao | Ankang Central Hospital | Principal Investigator |
| Long Zou | Shangluo Central Hospital | Principal Investigator |
| Ankang Central Hospital | Recruiting | Ankang | Shaanxi | China |
|
| Hanzhong 3201 Hospital | Recruiting | Hanzhong | Shaanxi | China |
|
| Shangluo Central Hospital | Recruiting | Shangluo | Shaanxi | China |
|
| Xijing hospital | Recruiting | Xi'an | Shaanxi | 710032 | China |
|
| Xi'an Central Hospital | Recruiting | Xi'an | Shaanxi | China |
|
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002757 | Cholanes |