Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-01-02 @ 11:47 PM
Study NCT ID:
NCT06610760
Status:
RECRUITING
Last Update Posted:
2025-12-05
First Post:
2024-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014580', 'term': 'Ursodeoxycholic Acid'}], 'ancestors': [{'id': 'D003840', 'term': 'Deoxycholic Acid'}, {'id': 'D002793', 'term': 'Cholic Acids'}, {'id': 'D001647', 'term': 'Bile Acids and Salts'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002757', 'term': 'Cholanes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 196}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2024-09-19', 'studyFirstSubmitQcDate': '2024-09-20', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The regression rate of gastric intestinal metaplasia based on OLGIM stage in different groups.', 'timeFrame': 'From enrollment to the end of treatment at 6 months', 'description': 'Regression was defined as a OLGIM stage decreased at least one grade.'}, {'measure': 'The progression rate of gastric intestinal metaplasia based on OLGIM stage in different groups.', 'timeFrame': 'From enrollment to the end of treatment at 6 months', 'description': 'Progression was defined as a OLGIM stage increased at least one grade.'}], 'secondaryOutcomes': [{'measure': 'The regression rate of gastric atrophy based on OLGA stage in different groups.', 'timeFrame': 'From enrollment to the end of treatment at 6 months', 'description': 'Regression was defined as a OLGA stage decreased at least one grade.'}, {'measure': 'The progression rate of gastric atrophy based on OLGA stage in different groups.', 'timeFrame': 'From enrollment to the end of treatment at 6 months', 'description': 'Progression was defined as a OLGA stage increased at least one grade.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Intestinal Metaplasia']}, 'descriptionModule': {'briefSummary': '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:\n\nDoes 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.\n\nParticipants will:\n\nTake ursodeoxycholic acid or a placebo every day for 6 months. Visit the clinic once every 4 weeks for checkups and tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged from 18 to 75 years old.\n* patients with OLGIM stage Ⅱ-Ⅳ diagnosed by upper gastrointestinal endoscopy and histopathological examination within the last 3 months.\n* patients without Helicobacter pylori infection, including patients who had successful Helicobacter pylori eradication before enrollment.\n\nExclusion Criteria:\n\n* a history of regular use (defined as at least once per week) of non-steroidal anti-inflammatory drugs (NSAIDs) and/or statins.\n* a history of stomach surgery (including endoscopic submucosal dissection and endoscopic mucosal resection) or previously diagnosed malignant tumor.\n* a history of heart failure, renal failure, liver cirrhosis or chronic hepatic failure; patients with contraindications or allergies to the drugs in this study.\n* breastfeeding or pregnancy.\n* a history of substance abuse or alcohol abuse within the past one year.\n* patients with severe mental illness.\n* refusal to undergo drug treatment.\n* refusal to sign informed consent.'}, 'identificationModule': {'nctId': 'NCT06610760', 'briefTitle': 'Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital of Digestive Diseases'}, 'officialTitle': 'Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia: A Multicenter, Randomized, Placebo-Controlled Trial', 'orgStudyIdInfo': {'id': 'KY20242225-F-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The ursodeoxycholic acid group', 'description': 'Patients in the ursodeoxycholic acid group will receive oral ursodeoxycholic acid at a dosage of 250 mg three times daily for 6 months.', 'interventionNames': ['Drug: Ursodeoxycholic Acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'The placebo group', 'description': 'Patients in the placebo group will receive oral placebo at a dosage of 250 mg three times daily for 6 months.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ursodeoxycholic Acid', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['The ursodeoxycholic acid group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['The placebo group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pingdingshan', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xinzhao Wang', 'role': 'CONTACT', 'email': 'xinzhw66@163.com', 'phone': '0375-3843070'}], 'facility': '989 Hospital of PLA Joint Logistics Support Force', 'geoPoint': {'lat': 33.73091, 'lon': 113.31554}}, {'city': 'Ankang', 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuan Gao', 'role': 'CONTACT', 'email': 'gaoyuan015@163.com', 'phone': '0915-2391384'}], 'facility': 'Ankang Central Hospital', 'geoPoint': {'lat': 32.68, 'lon': 109.01722}}, {'city': 'Hanzhong', 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhufang Ma', 'role': 'CONTACT', 'email': '369852677@qq.com', 'phone': '0916-2380433'}], 'facility': 'Hanzhong 3201 Hospital', 'geoPoint': {'lat': 33.07507, 'lon': 107.02214}}, {'city': 'Shangluo', 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ya Lan', 'role': 'CONTACT', 'email': 'lylan2013@163.com', 'phone': '0914-2360126'}], 'facility': 'Shangluo Central Hospital', 'geoPoint': {'lat': 33.86667, 'lon': 109.93056}}, {'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yongquan Shi Shi', 'role': 'CONTACT', 'email': 'shiyquan@fmmu.edu.cn', 'phone': '029-84771515'}], 'facility': 'Xijing hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kun Zhuang', 'role': 'CONTACT', 'email': '1033077816@qq.com', 'phone': '029-62812259'}], 'facility': "Xi'an Central Hospital", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Yongquan Shi', 'role': 'CONTACT', 'email': 'shiyquan@fmmu.edu.cn', 'phone': '0086 + 02984771515'}], 'overallOfficials': [{'name': 'Yongquan Shi, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Air Force Military Medical University, China'}, {'name': 'Xinzhao Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '989 Hospital of PLA Joint Logistics Support Force'}, {'name': 'Kun Zhuang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Xi'an Central Hospital"}, {'name': 'Zhufang Ma', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hanzhong 3201 Hospital'}, {'name': 'Yuan Gao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankang Central Hospital'}, {'name': 'Long Zou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shangluo Central Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yongquan Shi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yongquan Shi', 'investigatorAffiliation': 'Xijing Hospital of Digestive Diseases'}}}}