Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-02-23 @ 6:42 PM
Study NCT ID:
NCT03925818
Status:
TERMINATED
Last Update Posted:
2019-04-26
First Post:
2019-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Dose Bismuth Versus Lactobacillus Reuteri for H. Pylori Eradication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008795', 'term': 'Metronidazole'}, {'id': 'D013752', 'term': 'Tetracycline'}, {'id': 'D000077402', 'term': 'Pantoprazole'}, {'id': 'D001729', 'term': 'Bismuth'}], 'ancestors': [{'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D004603', 'term': 'Elements, Radioactive'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D011868', 'term': 'Radioisotopes'}, {'id': 'D007554', 'term': 'Isotopes'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'whyStopped': 'Lactobacillus reuteri (Gastrus®) was not anymore available in the region', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-24', 'studyFirstSubmitDate': '2019-04-19', 'studyFirstSubmitQcDate': '2019-04-23', 'lastUpdatePostDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Helicobacter pylori eradication rate', 'timeFrame': '30-40 days after the end of treatment', 'description': 'a negative 13C-urea breath test and/or a negative stool antigen test'}], 'secondaryOutcomes': [{'measure': 'Compliance and side effects evaluation', 'timeFrame': '30-40 days', 'description': 'Patient interview at the end of treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lactobacillus reuteri; Bismuth; Helicobacter pylori;'], 'conditions': ['Helicobacter Pylori Infection']}, 'descriptionModule': {'briefSummary': 'This study investigates the efficacy of a b.i.d. quadruple therapy containing Pylera® or L. reuteri for H. pylori infection.', 'detailedDescription': 'Bismuth, metronidazole and tetracycline yielded high cure rates for H. pylori infection. Earlier studies suggested that the bismuth quadruple therapy may be effective when given twice-a-day rather than q.i.d. and that b.i.d. therapy was associated with fewer side effects. The addition of the probiotic Lactobacillus reuteri (Gastrus®) to Lactobacillus reuteri (Gastrus®) that has been shown to increase the cure rates by 10-14%. In another study bismuth supplementation with L. reuteri DSM 17938, in a modified low dose quadruple therapy provided good eradication rates (93.3%; 95% CI : 85-99%) in clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Positive for H. pylori infection\n\nExclusion Criteria:\n\n* Presence of malignancy\n* Pregnancy or lactation\n* Clinically significant diseases\n* History of drug or alcohol abuse\n* Allergy to pantoprazole or to any component of regimens used in the study\n* Use of anti-secretory drugs, antibiotics or probiotics 4 weeks preceding the enrollment.'}, 'identificationModule': {'nctId': 'NCT03925818', 'acronym': 'LactoBismu', 'briefTitle': 'Low Dose Bismuth Versus Lactobacillus Reuteri for H. Pylori Eradication', 'organization': {'class': 'OTHER', 'fullName': 'Università degli Studi di Sassari'}, 'officialTitle': 'Twice-a-day PPI, Tetracycline, Metronidazolequadruple Therapy With Pylera® or Lactobacillus Reuteri for Treatment naïve or for Retreatment of H. Pylori: Two Randomized Pilot Studies', 'orgStudyIdInfo': {'id': '2358/CE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'B.I.D. TMPPI + Lactobacillus-10', 'description': 'pantoprazole 20 mg, tetracycline 500 mg, and metronidazole 500 mg twice a day supplemented with 1 capsule (2 x 108 CFU of L. reuteri DSM 17938 plus 2 x 108 CFU of L. reuteri ATCC PTA 6475) a day in the afternoon, given with the midday and evening meals for 10 days', 'interventionNames': ['Drug: Bismuth Subcitrate Potassium']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B.I.D. Bismuth', 'description': 'pantoprazole 20 mg and the same doses of antibiotics administered as tetracycline 250 mg, and metronidazole 250 mg plus 1 cp (140 mg bismuth subcitrate potassium, 125 mg metronidazole, and 125 mg tetracycline hydrochloride administered) x 2 all drugs twice-a-day given with the midday and evening meals for 10 days', 'interventionNames': ['Dietary Supplement: Gastrus']}], 'interventions': [{'name': 'Bismuth Subcitrate Potassium', 'type': 'DRUG', 'otherNames': ['Pylera', 'Metronidazole, Tetracycline, pantoprazole, Bismuth'], 'description': 'Pylera capsules', 'armGroupLabels': ['B.I.D. TMPPI + Lactobacillus-10']}, {'name': 'Gastrus', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475'], 'description': 'Gastrus 1 tablet', 'armGroupLabels': ['B.I.D. Bismuth']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07100', 'city': 'Sassari', 'state': 'SS', 'country': 'Italy', 'facility': 'Clinica Medica, Dipartimento di Medicina Clinica e Sperimentale', 'geoPoint': {'lat': 40.72586, 'lon': 8.55552}}], 'overallOfficials': [{'name': 'MARIA P Dore, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Università degli Studi di Sassari'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Università degli Studi di Sassari', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Maria Pina Dore', 'investigatorAffiliation': 'Università degli Studi di Sassari'}}}}