Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-04-05 @ 11:40 PM
Study NCT ID:
NCT02802059
Status:
COMPLETED
Last Update Posted:
2020-10-27
First Post:
2016-01-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
E. Coli Nissle 1917 - Suspension for Infection Prophylaxis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 567}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-26', 'studyFirstSubmitDate': '2016-01-18', 'studyFirstSubmitQcDate': '2016-06-13', 'lastUpdatePostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of infections', 'timeFrame': 'during the first 24 months of life', 'description': "The total number of infections observed for each participant during its individual study participation standardised per month during the first 24 months of life.\n\nAn infection is an episode of illness caused by:\n\n* Acute upper respiratory tract infections\n* Acute lower respiratory tract infections\n* Otitis media\n* Gastroenteritis\n* Urinary tract infections\n\nThe duration of an episode of illness is defined as the time from the appearance of the first symptom of a study relevant infection to the disappearance of the last symptom. Infections that occur concurrently or one after another within a period of 7 days are only counted separately, if they belong to different groups of illness.\n\nAll rhinitides that occur in the first year of a child's life are considered for the count of the primary efficacy variable. Rhinitides that occur in the second year will only be included if they were accompanied by fever (body temperature higher than 38.4°C during at least one measure)."}], 'secondaryOutcomes': [{'measure': 'Severity of the course of infections considered as primary variables quantified as the "duration of infections"', 'timeFrame': "during the first 24 months of infants' life", 'description': 'duration of infection = the number of days with at least one symptom'}, {'measure': 'Severity of the course of infections considered as primary variables quantified as the "number of hospital admissions caused by infections"', 'timeFrame': "during the first 24 months of infants' life", 'description': 'number of hospital admissions caused by infections'}, {'measure': 'Severity of the course of infections considered as primary variables quantified as the "mean number of in-hospital spent days due to infections"', 'timeFrame': "during the first 24 months of infants' life", 'description': 'mean number of in-hospital spent days due to infections'}, {'measure': 'Severity of the course of infections considered as primary variables quantified as the "number of antibiotic treatments due to infections".', 'timeFrame': "during the first 24 months of infants' life", 'description': 'number of antibiotic treatments due to infections'}, {'measure': 'Severity of the course of infections considered as primary variables quantified as the "number of adverse events".', 'timeFrame': "during the first 24 months of infants' life", 'description': 'number of adverse events'}, {'measure': 'Severity of the course of infections considered as primary variables quantified as the "tolerance to trial medication".', 'timeFrame': "during the first 24 months of infants' life", 'description': 'Tolerance of trial medication will be assessed by the investigator and scored "very good", "good", "moderate", or "poor".'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infections']}, 'descriptionModule': {'briefSummary': "This study evaluates the long term effects of E. coli strain Nissle 1917 (EcN-Suspension) probiotic bacteria administration on the number of both, bacterial and viral infections during the first 24 months of infant's life. Half of study participants will receive EcN-Suspension, while the other half will receive placebo. In an additional non-clinical explorative evaluation will furthermore be investigated whether the early intestinal colonization with E.coli strain Nissle 1917 affects the establishment of the intestinal microbiota.", 'detailedDescription': 'In the course of the present trial the participants will be observed during the first 24 months of life, starting right after birth.\n\nAll newborns meeting all inclusion criteria and non-fulfilling any exclusion criteria will be included into the trial. Each participant of this clinical trial will be randomly allocated to one of the two trial arms, by using the method of randomly permuted blocks.\n\nThe newborns will be primarily treated during the first three weeks of life and re-treated after 6 and 12 months according to trial interventional plan.\n\nData on the efficacy and safety will be recorded during control visits after first month, 6, 12, 18 and 24 months.\n\nA follow-up examination of study participants will be performed two years after the end of the participation in the present trial (i.e. at an age of 48 months), during which each child will be examined for its normal physical and cognitive development (covered by the U8 standardized examination). In addition data on allergic/atopic complaints or symptoms will be recorded.\n\nIn an additional non-clinical explorative evaluation, it will furthermore be investigated whether the early intestinal colonization with E.coli strain Nissle 1917 affects the establishment of the intestinal microbiota. Therefore stool samples of study participants will be collected at an age of 24 and 48 months. The microbial composition of these samples will be characterized and compared between the two trial arms (EcN vs. placebo).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '120 Hours', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed informed consent form by the parents\n* Age at inclusion: max. 120 hours after birth\n* Functionally mature infant\n* Gestational age more than 35th week of development\n* Mother's intention to breastfeed the participant\n* Readiness of the mother to administer no probiotics additionally to the trial medication\n\nExclusion Criteria:\n\n* Non-fulfilment of the at least one inclusion criteria\n* Lack of propensity/compliance of mother\n* 5 min APGAR SCORE less than 5\n* 10 min APGAR SCORE less than 8\n* pH of umbilical cord blood less than 7 (Determination not obligatory, if APGAR SCORES do not indicate that the child may have suffered from a perinatal asphyxia)\n* Any perinatal infection required antibiotic treatment\n* Birth weight less than 2000 g\n* TORCH-infection of the mother\n* HIV-infection of the mother\n* Any severe medical condition of mother or newborn which in the opinion of the investigator may have a critical impact on the conduct of the study."}, 'identificationModule': {'nctId': 'NCT02802059', 'acronym': 'RONi', 'briefTitle': 'E. Coli Nissle 1917 - Suspension for Infection Prophylaxis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ardeypharm GmbH'}, 'officialTitle': 'E. Coli Nissle 1917 - Suspension for Infection Prophylaxis', 'orgStudyIdInfo': {'id': 'MU 1441'}, 'secondaryIdInfos': [{'id': '2015-001763-39', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EcN-Suspension', 'description': '279 healthy functionally mature newborn infants up to 35 weeks gestational age, treated with EcN-Suspension', 'interventionNames': ['Drug: EcN-Suspension']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '279 healthy functionally mature newborn infants up to 35 weeks gestational age, treated with Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'EcN-Suspension', 'type': 'DRUG', 'otherNames': ['E. coli strain Nissle 1917 bacteria'], 'description': 'Initial administration not later than 120h after birth. 14 ampoules a 1 ml are administered within a time of 3 weeks (1 ampoule per day within first week and 1 ampoule every second day within the following two weeks).\n\nSubsequent re-administration after 6 and 12 months. 10 ampoules a 1 ml are administered within 10 days (1 ampoule per day).', 'armGroupLabels': ['EcN-Suspension']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Initial administration not later than 120h after birth. 14 ampoules a 1 ml are administered within a time of 3 weeks (1 ampoule per day within first week and 1 ampoule every second day within the following two weeks).\n\nSubsequent re-administration after 6 and 12 months. 10 ampoules a 1 ml are administered within 10 days (1 ampoule per day).', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06110', 'city': 'Halle', 'country': 'Germany', 'facility': 'Krankenhaus St. Elisabeth & St. Barbara', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '07747', 'city': 'Jena', 'country': 'Germany', 'facility': 'Universitätsklinikum Jena - Klinik für Kinder- und Jugendmedizin', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '14467', 'city': 'Potsdam', 'country': 'Germany', 'facility': 'Klinikum Westbrandenburg', 'geoPoint': {'lat': 52.39886, 'lon': 13.06566}}, {'zip': '18059', 'city': 'Rostock', 'country': 'Germany', 'facility': 'Klinikum Südstadt Rostock - Abteilung für Neonatologie', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'zip': '85-168', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Oddział Kliniczny Noworodków, Wcześniaków z Intensywną Terapią Noworodka wraz z Wyjazdowym Zespołem "N"', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '02-091', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Samodzielny Publiczny Dziecięcy Szpital Kliniczny Oddział Kliniczny Neonatologiiul', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Corinna Wolff, Dipl-Biophys', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ardeypharm GmbH'}, {'name': 'Dirk M Olbertz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum Südstadt Rostock - Abteilung für Neonatologie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ardeypharm GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'ICON plc', 'class': 'INDUSTRY'}, {'name': 'Clinscience Sp. z o.o.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}