Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-02-22 @ 4:53 PM
Study NCT ID:
NCT03150394
Status:
UNKNOWN
Last Update Posted:
2017-08-25
First Post:
2017-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Usefulness of the Probiotic 'Lactobacillus Reuteri' in the Therapy of Quadruple Eradication of Helicobacter Pylori Infection in Usual Clinical Practice.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-09-18', 'releaseDate': '2020-08-30'}], 'estimatedResultsFirstSubmitDate': '2020-08-30'}}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-24', 'studyFirstSubmitDate': '2017-05-05', 'studyFirstSubmitQcDate': '2017-05-11', 'lastUpdatePostDateStruct': {'date': '2017-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global score of gastrointestinal symptoms assessed according the GSRS scale', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Score obtained from each individual gastrointestinal symptom evaluated according the GSRS scale. Percentage of patients completing treatment', 'timeFrame': '60 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Helicobacter Pylori Infection']}, 'descriptionModule': {'briefSummary': "Helicobacter pylori is a Gram-negative bacterium with a helical bacillus shape that it's able to penetrate and colonize the stomach mucosal lining by infecting it.\n\nThe eradication treatment of H. pylori is supported by numerous consensus groups worldwide and it is generally safe and well tolerated. Standard treatment is based on multiple drug regimens. However, its effectiveness has been increasingly compromised due to the emergence of resistant strains, as well as poor adherence to treatment. Therefore, it's proposed a randomized, double-blind, placebo-controlled study whose aims are:\n\n1. Determine whether the combination of two probiotic strains of L reuteri (Gastrus) will improve gastrointestinal symptoms when associated with four-way therapy (of any type).\n2. Prove whether supplementation with Gastrus (food supplement) versus Placebo is able to reduce the gastrointestinal adverse effects of quadruple eradication therapy.\n\nThey will be determined by the GSRS gastrointestinal symptom scale in routine clinical practice."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients attended at the clinic visit who present a positive diagnosis of H pylori infection using different diagnostic techniques (C13 breath test, histology, urease and / or H pylori antigen in stools).\n* Age between 18 and 65 years\n\nExclusion Criteria:\n\n* Patients taking other probiotics 4 weeks prior to study start.\n* Patients who have previously received eradicating therapy.\n* Patients who are treated with NSAIDs, aspirin or other anti-inflammatory drugs either on an occasional basis (one week prior to the study) or on a chronic basis (3 weeks prior to inclusion).\n* Patients who have used oral antibiotics two weeks prior to inclusion.\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03150394', 'briefTitle': "Study of the Usefulness of the Probiotic 'Lactobacillus Reuteri' in the Therapy of Quadruple Eradication of Helicobacter Pylori Infection in Usual Clinical Practice.", 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clínico Universitario de Valladolid'}, 'officialTitle': "A Randomized, Double-blind, Placebo-controlled Study of the Usefulness of the Probiotic 'Lactobacillus Reuteri' in the Therapy of Quadruple Eradication of Helicobacter Pylori Infection in Usual Clinical Practice", 'orgStudyIdInfo': {'id': 'VALACT-2017-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment of quadruple eradication therapy with GASTRUS', 'interventionNames': ['Dietary Supplement: GASTRUS']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment of quadruple eradication therapy with PLACEBO', 'interventionNames': ['Other: PLACEBO']}], 'interventions': [{'name': 'GASTRUS', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Gastrus will be given from the first day of eradication treatment to completion after 30 days of treatment', 'armGroupLabels': ['Treatment of quadruple eradication therapy with GASTRUS']}, {'name': 'PLACEBO', 'type': 'OTHER', 'description': 'Placebo will be given from the first day of eradication treatment to completion after 30 days of treatment', 'armGroupLabels': ['Treatment of quadruple eradication therapy with PLACEBO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47003', 'city': 'Valladolid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Luis Fernandez, PhD', 'role': 'CONTACT', 'email': 'luisfernsal@gmail.com', 'phone': '+34607537815'}], 'facility': 'Hospital Clinico Universitario de Valladolid', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}, {'zip': '47012', 'city': 'Valladolid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jesus Barrio, PhD', 'role': 'CONTACT', 'email': 'jbarrioa95@gmail.com'}], 'facility': 'Hospital Universitario Río Hortega.', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}], 'centralContacts': [{'name': 'Luis Fernandez, PhD', 'role': 'CONTACT', 'email': 'luisfernsal@gmail.com', 'phone': '+34607537815'}, {'name': 'Jesus Barrio, PhD', 'role': 'CONTACT', 'email': 'jbarrioa95@gmail.com'}], 'overallOfficials': [{'name': 'Dr. Fernandez Dr. Jesus Barrio', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Managers study'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Luis Fernandez', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Dr. Luis Fernandez', 'investigatorAffiliation': 'Hospital Clínico Universitario de Valladolid'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-08-30', 'type': 'RELEASE'}, {'date': '2020-09-18', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Dr. Luis Fernandez, PhD, Hospital Clínico Universitario de Valladolid'}}}}