Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 11:14 PM
Study NCT ID:
NCT07129460
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-04
First Post:
2025-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Berberine for Gastric Intestinal Metaplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 204}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2025-08-12', 'studyFirstSubmitQcDate': '2025-08-12', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', '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': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Intestinal Metaplasia']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to investigate the efficacy of Berberine in treating gastric intestinal metaplasia in Helicobacter pylori-negative adults. It will also learn about the safety of Berberine. The main questions it aims to answer are:\n\nDoes Berberine promote the regression of IM in individuals without Helicobacter pylori infection? What medical problems do participants experience when taking Berberine? Researchers will compare Berberine to a placebo (a look-alike substance that contains no drug) to see if uBerberine is effective in treating gastric intestinal metaplasia.\n\nParticipants will:\n\nTakeBerberine 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/or Metformin.\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': 'NCT07129460', 'briefTitle': 'Efficacy and Safety of Berberine for Gastric Intestinal Metaplasia', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital of Digestive Diseases'}, 'officialTitle': 'Efficacy and Safety of Berberine for Gastric Intestinal Metaplasia: a Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'KY20252248-F-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The Berberine group', 'description': 'Patients in the Berberine group will receive oral Berberine hydrochloride at a dosage of 300 mg two times daily for 6 months', 'interventionNames': ['Drug: Berberine hydrochloride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'The placebo group', 'description': 'Patients in the placebo group will receive oral placebo at a dosage of 300 mg two times daily for 6 months', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Berberine hydrochloride', 'type': 'DRUG', 'description': 'Subjects will be instructed to take three tablets (300mg) of Berberine hydrochloride two 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 Berberine group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subjects will be instructed to take three tablets (300mg) of placebo two 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': {'centralContacts': [{'name': 'Yongquan Shi Shi', 'role': 'CONTACT', 'email': 'shiyquan@fmmu.edu.cn', 'phone': '029-84771515'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital of Digestive Diseases', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yongquan Shi', 'investigatorAffiliation': 'Xijing Hospital of Digestive Diseases'}}}}