Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-03 @ 6:45 PM
Study NCT ID:
NCT03377933
Status:
UNKNOWN
Last Update Posted:
2019-06-24
First Post:
2017-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects Probiotic Has on Gastromicroecology and Combined With Quadruple Regimen for H Pylori Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single-center exploratory study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2020-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-20', 'studyFirstSubmitDate': '2017-12-01', 'studyFirstSubmitQcDate': '2017-12-16', 'lastUpdatePostDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'gene-level changes in the gastric microbiota', 'timeFrame': '2 weeks', 'description': 'study gene-level changes through gene sequencing in the gastric microbiota following use of probiotics'}], 'secondaryOutcomes': [{'measure': 'eradication rate of the therapy', 'timeFrame': '4 weeks', 'description': 'using the 13C-urea breath test at 4 weeks after the end of therapy'}, {'measure': 'the incidence of the adverse effects', 'timeFrame': '2 weeks, 4 weeks', 'description': 'record the side effects on the 2 week, 4 week.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Helicobacter pylori', 'Probiotics', 'Efficacy', 'Safety', 'gastromicroecology'], 'conditions': ['Efficacy', 'Gastric Microbiota', 'Safety']}, 'descriptionModule': {'briefSummary': 'This study assesses the efficacy and safety of treatment with two-week probiotics followed by a 10-day tetracycline- and furazolidone-containing quadruple regimen as rescue treatment for H. pylori infection. Eradication was evaluated using the 13C-urea breath test at 4 weeks after the end of therapy, and side effects were recorded. Besides study gene-level changes in the gastric microbiota following use of probiotics.', 'detailedDescription': 'Currently the infection rate of H. pylori is high. H. pylori infection has a close relationship with human diseases , Among the patients with H. pylori infection, 100% have active gastritis, \\<10% show H. pylori related dyspepsia, 15%\\~20% develop into peptic ulcer, \\<1% ultimately evolve into gastric malignant tumor. H. pylori gastritis has been defined as an infective disease. Eradication of H. pylori plays an important role in the cure, reversal and delay of these diseases.\n\nWith the widespread eradication of H. pylori, antibiotics resistance rates are increasing seriously. The resistance of antibiotics results in the increase of H. pylori eradication failure rate. Choosing a safe and effective scheme for patients who have failed multiple times is a challenge for the clinicians.\n\nBesides, both domestic and international consensuses point that the application of some probiotics can reduce adverse effects through regulating gastric microenvironment, and it is still controversial about whether probiotics can inhibit H. pylori to increase the eradication rate.\n\nInvestigators previously retrospectively analyzed 30 patients with H. pylori eradication failures at least two times given two-week compound Lactobacillus acidophilus followed with 10-day tetracycline- and furazolone- containing quadruple regimen, the ITT eradication rate was 92.1%, and 94.6% PP analysis. Side effects were mild mainly including dizziness, dry mouth and skin rash occurred in eight patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All included patients were 18 to 70 years-old; negative for the urea breath test at least 4 weeks after last eradication treatment; and experienced at least 2 H. pylori eradication failures.\n\nExclusion Criteria:\n\n* Patients were excluded if they presented with a severe comorbidity or a malignant tumor; had a known history of allergy to the drugs in the therapeutic regimen; used nonsteroidal anti-inflammatory drugs (NSAIDs), antibiotic therapy, or bismuth salts up to 4 weeks before study inclusion; or were pregnant or breast-feeding.'}, 'identificationModule': {'nctId': 'NCT03377933', 'briefTitle': 'The Effects Probiotic Has on Gastromicroecology and Combined With Quadruple Regimen for H Pylori Infection', 'organization': {'class': 'OTHER', 'fullName': 'Changhai Hospital'}, 'officialTitle': 'The Effects of Compound Lactobacillus Acidophilus Has on Gastromicroecology and Combined With Tetracycline- and Furazolidone- Containing Quadruple Regimen as Rescue Treatment for Helicobacter Pylori Infection', 'orgStudyIdInfo': {'id': 'chbs230023-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'probiotics and quadruple therapy', 'description': 'Patients are given two-week compound Lactobacillus acidophilus probiotic (1 g t.i.d.), followed by a quadruple antibiotic regimen (esomeprazole \\[20 mg b.i.d.\\] + bismuth potassium citrate \\[220 mg b.i.d.\\] + tetracycline \\[750 mg b.i.d.\\] + furazolidone \\[100 mg b.i.d.\\]) for 10 days as rescue therapy.Meanwhile perform endoscopy and take gastric mucosa specimens for gene sequencing before and after the application of probiotic.', 'interventionNames': ['Other: Compound Lactobacillus acidophilus']}], 'interventions': [{'name': 'Compound Lactobacillus acidophilus', 'type': 'OTHER', 'otherNames': ['Yi Jun Kang'], 'description': 'Compound Lactobacillus acidophilus Tablet', 'armGroupLabels': ['probiotics and quadruple therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yiqi Du', 'role': 'CONTACT'}], 'facility': 'Changhai hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yi Qi Du, professor', 'role': 'CONTACT', 'email': 'duyiqi@hotmail.com', 'phone': '+8613801993592'}], 'overallOfficials': [{'name': 'Yi Qi Du, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'study protocal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yiqi Du', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Vice Director of Department of Gastroenterology', 'investigatorFullName': 'Yiqi Du', 'investigatorAffiliation': 'Changhai Hospital'}}}}