Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-29 @ 7:32 PM
Study NCT ID:
NCT05561504
Status:
RECRUITING
Last Update Posted:
2023-11-30
First Post:
2022-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Helicobacter Pylori Local Prevalence and Antibiotic Resistance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D003141', 'term': 'Communicable Diseases'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood samples, fecal samples, gastric biopsies'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2035-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-29', 'studyFirstSubmitDate': '2022-09-27', 'studyFirstSubmitQcDate': '2022-09-27', 'lastUpdatePostDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'H. pylori prevalence', 'timeFrame': '6 months', 'description': 'Prevalence of H. pylori infection in a random sample of the populations of Munich, Tübingen, Hannover, Regensburg, Magdeburg and their respective surroundings'}, {'measure': 'H. pylori resistance profiles', 'timeFrame': '6 months', 'description': 'H. pylori isolation and antibiotic resistance testing from gastric mucosa biopsies'}], 'secondaryOutcomes': [{'measure': 'H. pylori strain analyses', 'timeFrame': '1 year', 'description': 'H. pylori subtype determination via antibody responses in serum and sequencing of H. pylori strains'}, {'measure': 'subsequent medical events', 'timeFrame': '10 years', 'description': 'survey-based follow up of participants at 5 and 10 years for subsequent medical conditions'}, {'measure': 'risk factors for gastric cancer', 'timeFrame': '10 years', 'description': 'Correlation of microbiological and serological findings with gastric histopathology and subsequent cancer diagnoses'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Helicobacter Pylori Infection', 'Helicobacter Pylori Gastritis', 'Drug Resistant Bacterial Infection', 'Antibiotic Resistant Infection', 'Gastric Cancer', 'Microbial Colonization']}, 'descriptionModule': {'briefSummary': 'The clinical management of H. pylori infection depends essentially on two factors, prevalence and local resistance. In Germany, only limited data from rather small cohorts currently exist regarding both factors. Knowledge of the current prevalence (accounting for socioeconomic factors and age) is important for the selection of suitable detection methods, as this influences the positive and negative predictive value of the respective diagnostic methods. Current data on antibiotic resistance are essential for efficient therapy. In this clinical study, we will collect data on the frequency and severity of H. pylori infections and then, after endoscopic examination, on antibiotic resistance. Knowledge of the resistance situation is necessary for the selection of suitable therapeutic regimens. Furthermore, molecular methods for resistance detection are to be compared with conventional microbiological methods in order to be able to detect resistance more quickly. Furthermore, we aim to identify specific parameters for early detection of patients at particularly high risk of gastric cancer or with precancerous lesions due to infection. The aim is to identify carcinogenesis-relevant factors such as gastric microbiome signatures that will make it possible to identify patients who are most likely to benefit from prophylactic eradication therapy in terms of risk stratification.', 'detailedDescription': 'Infection with H. pylori occurs in childhood and usually leads to lifelong persistence of the pathogen. The prevalence of the infection depends on socioeconomic status (occupation, income, housing situation), especially during childhood, when the transmission occurs most frequently. H. pylori infections are most common in East Asia, e.g. China, with prevalence rates of around 60-80 %, and in Africa, with prevalence rates of partly over 80 %. In Europe, there is a south-north divide in infection rates with a higher prevalence in southern countries. The prevalence in Germany varies between 21% for the Hannover area and 44% for Saxony-Anhalt; the prevalence in children is significantly lower than in adults. Current data on the larger population in Germany are lacking. While antibiotics in combination with PPIs can be used to treat the infection, rising antibiotic resistance rates reduce effectiveness of eradication regimens.\n\nWe therefore initiated a multicenter observational study to assess the prevalence of H. pylori infection and antibiotic resistance rates in Germany. In Part A, volunteers are screened for H. pylori infection by serology. If the test is positive, a breath test is performed for confirmation and further visits and examinations follow for long-term observation. Positive patients undergoing endoscopy can enter Part B, in which biopsies are taken for antibiotic resistance, and establishment of a serum, stool and a tissue bank for molecular analysis including microbiome sequencing.\n\nPart A - Primary study objectives - screening phase The primary aim of this part of the study is to collect data on the prevalence of H. pylori in an age- and gender-stratified random sample of the populations of Munich, Tübingen, Hannover, Regensburg, and Magdeburg and their respective surroundings. If the initial serologic test is negative, no further study visits are planned for these subjects. The serum samples already collected will be used as control samples for the serologic study. If the serologic test is positive, a breath test is performed for confirmation. If the confirmatory breath test is positive and the subject is evaluated by his/her primary doctor and deemed a candidate for endoscopic evaluation, then s/he is referred for participation in part B of the study.\n\nPart B - Secondary study objectives - investigation phase\n\nAs secondary study objectives, the following should be investigated in H. pylori infected study participants:\n\n* Establishment of a patient cohort for long-term observation (5-10 years).\n* Establishment of a serum, stool and tissue bank in this cohort for subsequent testing:\n\n * H. pylori subtype determination for gastric cancer risk, early detection via antibody responses in serum, identification of risk factors\n * PCR or sequencing of H. pylori strains (from stomach biopsy or stool sample)\n * H. pylori isolation and antibiotic resistance testing from gastric mucosa biopsies, only to be performed as part of a clinically indicated esophago-gastro- duodenoscopy - ÖGD (for diagnosis before initiation of therapy or also after completion of therapy to monitor success or progression)\n * Correlation of microbiological findings with histopathological findings and atrophy markers.\n* Determination of H. pylori associated microbiome characteristics and microbiome changes after eradication therapy\n\nOnly patients undergoing gastroscopy for clinical indications are included into Part B of the study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'unselected group of participants', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minimum age of 18 years\n* informed consent for HelicoPTER study\n* informed consent for HEPY biobank\n\nExclusion Criteria:\n\n* no capacity to consent'}, 'identificationModule': {'nctId': 'NCT05561504', 'acronym': 'HelicoPTER', 'briefTitle': 'Helicobacter Pylori Local Prevalence and Antibiotic Resistance', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'HelicoPTER - Bestimmung Der Lokalen Helicobacter Pylori Prävalenz Und Antibiotika Resistenzlage', 'orgStudyIdInfo': {'id': 'GI 06.827'}}, 'contactsLocationsModule': {'locations': [{'city': 'Munich', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christian Schulz, MD', 'role': 'CONTACT'}], 'facility': 'Department of Medicine II, University Hospital of Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'centralContacts': [{'name': 'Markus Gerhard, Prof.', 'role': 'CONTACT', 'email': 'markus.gerhard@tum.de', 'phone': '+49894140', 'phoneExt': '2477'}], 'overallOfficials': [{'name': 'Markus Gerhard, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Technical University of Munich'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'IPD will be made available after closing of recruitment (12/2025) for a duration of 10 years', 'ipdSharing': 'YES', 'accessCriteria': 'data transfer request with detailed outline of scientific questions and aims'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}