Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2025-12-24 @ 3:03 PM
Study NCT ID:
NCT04618159
Status:
COMPLETED
Last Update Posted:
2020-11-05
First Post:
2018-10-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Does Helipyl Eradicate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'helipyl is given to patients with non symptomatic helicobacter pylori infection'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-04', 'studyFirstSubmitDate': '2018-10-08', 'studyFirstSubmitQcDate': '2020-11-04', 'lastUpdatePostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to evaluate the C13 breathtest', 'timeFrame': '6months', 'description': 'evaluation of C13 breathtest before, at the end of treatment and one month after treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Eradication']}, 'descriptionModule': {'briefSummary': 'Helipyl is on the market; actually it is a post-biotic because it is a killed Lactobacillus reuteri DSMZ 17648. The aim is to demonstrate (or not) that this product eradicates helicobacter, which it claims to do.', 'detailedDescription': 'This is a pilot project. There is quite limited literature on this product and Helicobacter pylori eradication. My personal opinion is that the literature and guidelines are contradictory. The European guideline is that Helicobacter pylori should not be corrected unless there are "serious" symptoms . On the other hand, Helicobacter is a carcinogen. Quite often, parents ask us, children\'s gastroenterologists, to screen their children for Helicobacter because they are symptomatic and are being eradicated, and know that Helicobacter is contagious. This creates a difficult situation: not answering the question is not an option according to the parents\' opinion. Going into the question and eradicating "classic" is against all guidelines.\n\nHence this pilot project: 10 complaints-free carriers of Helicobacter pylori (\\> 5 years) will be treated with Helipyl for one month (product supplied by the company). Beforehand, at the end of the treatment and a month after stopping of the treatment, we do a C13 breath test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>5 and \\<18 years\n* male and female\n* asymptomatic helicobacter pylori\n\nExclusion Criteria:\n\n* helicobacter pylori infection with symptoms\n* \\<5 years'}, 'identificationModule': {'nctId': 'NCT04618159', 'acronym': 'Helipyl', 'briefTitle': 'Does Helipyl Eradicate', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'Does Helipyl Eradicate', 'orgStudyIdInfo': {'id': '2018-380'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Helipyl', 'description': 'helipyl wil be given to 10 children with asymptomatical helicobacter pylori infection', 'interventionNames': ['Other: lactobacillus reuteri DSMZ 17648']}], 'interventions': [{'name': 'lactobacillus reuteri DSMZ 17648', 'type': 'OTHER', 'description': 'to evaluate if this product can eradicate helicobacter pylori', 'armGroupLabels': ['Helipyl']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Brussels', 'state': 'Brussel Hoofdstedelijk Gewest', 'country': 'Belgium', 'facility': 'UZ Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'head of departement', 'investigatorFullName': 'Yvan Vandenplas', 'investigatorAffiliation': 'Universitair Ziekenhuis Brussel'}}}}