Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:45 AM
Study NCT ID:
NCT05483660
Status:
UNKNOWN
Last Update Posted:
2022-08-02
First Post:
2022-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial on the Efficacy of Gastric Probiotics in the Treatment of Helicobacter Pylori Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C562118', 'term': 'exopolysaccharide biopolymer, Bacillus coagulans'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'The person in charge of assigning patients to treatment groups does not know which treatments the patients receive, so they do not select patients in order of their own volition.\n\nPatients themselves do not know what treatment they are receiving, so they do not change their compliance or reporting of symptoms.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-29', 'studyFirstSubmitDate': '2022-07-24', 'studyFirstSubmitQcDate': '2022-07-29', 'lastUpdatePostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eradication of Helicobacter pylori', 'timeFrame': 'The eighth week of the trial', 'description': 'All participants will have a 13C-urea breath test to see if their 13C value falls below the threshold for H. pylori eradication.'}], 'secondaryOutcomes': [{'measure': 'The condition of gastrointestinal symptoms before the trial', 'timeFrame': 'Baseline', 'description': 'We will use Gastrointestinal symptoms rating scale (GSRS) to know about the baseline level of their gastrointestinal symptoms before they receive the probiotic or placebo.'}, {'measure': 'The condition of gastrointestinal symptoms in the first week', 'timeFrame': 'The first week of the trial.', 'description': 'We will use Gastrointestinal symptoms rating scale (GSRS) to know about the level of their gastrointestinal symptoms after they receive the probiotic or placebo already a week.'}, {'measure': 'The condition of gastrointestinal symptoms in the second week', 'timeFrame': 'The second week of the trial.', 'description': 'We will use Gastrointestinal symptoms rating scale (GSRS) to know about the level of their gastrointestinal symptoms after they receive the probiotic or placebo after two weeks.'}, {'measure': 'The condition of gastrointestinal symptoms in the third week', 'timeFrame': 'The third week of the trial.', 'description': 'We will use Gastrointestinal symptoms rating scale (GSRS) to know about the level of their gastrointestinal symptoms after they receive the probiotic or placebo after three weeks.'}, {'measure': 'The condition of gastrointestinal symptoms in the fourth week', 'timeFrame': 'The fourth week of the trial.', 'description': 'We will use Gastrointestinal symptoms rating scale (GSRS) to know about the level of their gastrointestinal symptoms at the fourth week of this trial.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastric Probiotics', 'Side-effect', 'Eradication rate', 'Helicobacter pylori'], 'conditions': ['Helicobacter Pylori Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and efficacy of Lactobacillus plantarum, Bacillus coagulans and Lactobacillus plantarum + Bacillus coagulans for eradication of Helicobacter Pylori, as well as the efficacy of Lactobacillus plantarum and Bacillus coagulans on side-effect caused by Helicobacter Pylori.', 'detailedDescription': "All patients included in this randomized controlled clinical trial will be selected according to strict inclusion and exclusion criteria. At the same time, the benefits and risks of participating in this trial will be explained to the patients before the start of the study, the patients' right to informed consent will be respected, and the informed consent will be signed. After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner (participants and investigator) in a 1:1:1:1 ratio to Lactobacillus plantarum (1.5×10\\^10 per time, three times daily) or Bacillus coagulans (1.5×10\\^10 per time, three times daily) or Lactobacillus plantarum + Bacillus coagulans (1.5×10\\^10 per time, three times daily) or placebo ( 15g per time, three times daily). At the same time, volunteers will be recruited from healthy people to perform the same treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-75 years.\n* Diagnosed by 13C-UBT within 2 weeks before entry.\n\nExclusion Criteria:\n\n* Previous treatment for H. pylori infection.\n* Administration of antibiotics, probiotics/prebiotics, PPIs, H2 receptor antagonists, bismuth preparations, laxatives, anti-diarrhoeals, and certain antimicrobial traditional Chinese medicines 4 weeks before.\n* Previous history of gastrointestinal surgery.\n* Severe or unstable diseases.\n* Pregnancy or lactation.\n* Alcoholics and drug abusers.\n* Staff of this trial.'}, 'identificationModule': {'nctId': 'NCT05483660', 'briefTitle': 'A Clinical Trial on the Efficacy of Gastric Probiotics in the Treatment of Helicobacter Pylori Infection', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'A Randomized, Controlled, Double-blind Trial on the Efficacy of Gastric Probiotics in the Treatment of Helicobacter Pylori Infection', 'orgStudyIdInfo': {'id': 'NFEC-2022-252'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lactobacillus plantarum', 'description': '1.5×10\\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.', 'interventionNames': ['Other: Lactobacillus plantarum']}, {'type': 'EXPERIMENTAL', 'label': 'Bacillus coagulans', 'description': '1.5×10\\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.', 'interventionNames': ['Other: Bacillus coagulans']}, {'type': 'EXPERIMENTAL', 'label': 'Lactobacillus plantarum + Bacillus coagulans', 'description': '1.5×10\\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.', 'interventionNames': ['Other: Lactobacillus plantarum + Bacillus coagulans']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Adult milk powder 15 g per time, three times daily and half an hour before meal.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Lactobacillus plantarum', 'type': 'OTHER', 'description': '1.5×10\\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.', 'armGroupLabels': ['Lactobacillus plantarum']}, {'name': 'Bacillus coagulans', 'type': 'OTHER', 'description': '1.5×10\\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.', 'armGroupLabels': ['Bacillus coagulans']}, {'name': 'Lactobacillus plantarum + Bacillus coagulans', 'type': 'OTHER', 'description': '1.5×10\\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.', 'armGroupLabels': ['Lactobacillus plantarum + Bacillus coagulans']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Adult milk powder 15 g pertime, three times daily and half an hour before meal.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yang Bai', 'role': 'CONTACT', 'email': '13925001665@163.com', 'phone': '13925001665'}, {'name': 'Hongying Fan', 'role': 'CONTACT', 'email': 'biofhy@126.com', 'phone': '13631381172'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'The data will be available after August 31, 2025, and will be permanently public.', 'ipdSharing': 'YES', 'accessCriteria': 'Everyone'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}