Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2026-01-26 @ 7:29 PM
Study NCT ID:
NCT02197468
Status:
COMPLETED
Last Update Posted:
2019-03-11
First Post:
2014-07-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preterm Infant Gut (PINGU) - a Norwegian Multi Centre Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D020345', 'term': 'Enterocolitis, Necrotizing'}], 'ancestors': [{'id': 'D004760', 'term': 'Enterocolitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Fecal samples for bacterial DNA analyses'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-07', 'studyFirstSubmitDate': '2014-07-21', 'studyFirstSubmitQcDate': '2014-07-21', 'lastUpdatePostDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cross contamination of probiotic bacteria in a NICU', 'timeFrame': '7 days of age and 4 weeks of age', 'description': 'Detection of probiotic bacterial microbiome profiles in children not receiving probiotics'}], 'primaryOutcomes': [{'measure': 'To assess gut microbiome composition (meta genome sequencing) of preterm infants receiving probiotics versus preterm infants not receiving probiotics', 'timeFrame': '4 time points: 7 days of age, 4 weeks of age, 4 months corrected age and 12 months corrected age', 'description': 'Stools samples from preterm infants and term infants (control)'}], 'secondaryOutcomes': [{'measure': 'Impact of antibiotic exposure on gut microbiome', 'timeFrame': '4 time points: 7 days of age, 4 weeks of age, 4 months corrected age and 12 months corrected age', 'description': 'Stool samples from preterm and term infants'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gut microbiome', 'Necrotizing enterocolitis', 'Antibiotics'], 'conditions': ['Mixed Flora; Infection']}, 'referencesModule': {'availIpds': [{'url': 'https://www.frontiersin.org/articles/10.3389/fped.2018.00347/full', 'type': 'Clinical Study Report', 'comment': 'Publication from this study'}], 'references': [{'pmid': '24751892', 'type': 'BACKGROUND', 'citation': 'Berrington JE, Stewart CJ, Cummings SP, Embleton ND. The neonatal bowel microbiome in health and infection. Curr Opin Infect Dis. 2014 Jun;27(3):236-43. doi: 10.1097/QCO.0000000000000061.'}, {'pmid': '22845166', 'type': 'BACKGROUND', 'citation': 'Stewart CJ, Marrs EC, Magorrian S, Nelson A, Lanyon C, Perry JD, Embleton ND, Cummings SP, Berrington JE. The preterm gut microbiota: changes associated with necrotizing enterocolitis and infection. Acta Paediatr. 2012 Nov;101(11):1121-7. doi: 10.1111/j.1651-2227.2012.02801.x. Epub 2012 Aug 31.'}, {'pmid': '30505830', 'type': 'DERIVED', 'citation': 'Esaiassen E, Hjerde E, Cavanagh JP, Pedersen T, Andresen JH, Rettedal SI, Stoen R, Nakstad B, Willassen NP, Klingenberg C. Effects of Probiotic Supplementation on the Gut Microbiota and Antibiotic Resistome Development in Preterm Infants. Front Pediatr. 2018 Nov 16;6:347. doi: 10.3389/fped.2018.00347. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'Necrotizing enterocolitis (NEC) is a leading cause of morbidity and mortality among infants in the neonatal intensive care unit (NICU). It has been postulated that abnormal colonization of the preterm gut, or an unfavorable balance between gut bacteria may contribute to the development of NEC.\n\nRecent clinical randomized studies and meta-analysis have shown that proactive colonization of probiotic bacteria reduce the frequency of NEC. Based on this evidence, in April 2014 all Norwegian NICUs started routinely administration of probiotics to all extremely premature neonates susceptible to NEC (gestational age \\<28 weeks/birth weight \\<1000g).\n\nThe current project is investigating the gut microbiome in patients receiving probiotics and compare the the gut microbiome with moderate premature infants not receiving probiotics. In addition, we are including a control of healthy full-term infants.\n\nSamples containing feces from participants will be analyzed by state of the art whole-genome sequencing techniques. Bacterial diversity will be analysed with bioinformatic tools.\n\nStudy hypotheses:\n\n* Probiotics given to extremely preterm infants will change the biodiversity of the gut microflora.\n* Antibiotics given to these patients may influence the gut microflora also in infants receiving probiotics. In particular use of vancomycin may change the gut flora.\n* After cessation of probiotic prophylaxis the gut flora of infants receiving probiotics will gradually resemble the gut flora of infants not receiving probiotics.\n* A cross-contamination of probiotic bacteria between patients treated with probiotics and patients not treated with antibiotics may occur.', 'detailedDescription': 'Necrotizing enterocolitis (NEC) is a leading cause of morbidity and mortality among infants in the neonatal intensive care unit (NICU). Prematurity is the most important risk factor for NEC. The pathogenesis of NEC remains unclear, and prevention and treatment strategies are limited. It has been postulated that abnormal colonization of the preterm gut, or an unfavorable balance between gut bacteria, is significant in the pathogenesis of NEC.\n\nRecent clinical randomized studies and meta-analysis have shown that proactive colonization of probiotic bacteria reduce the frequency of NEC. Based on this evidence, in April 2014 all Norwegian NICUs started routinely administration of probiotics to all extremely premature neonates susceptible to NEC (gestational age (GA) \\<28 weeks/birth birth weight (BW) \\<1000 g).\n\nThe current project is investigating the gut microbiome in patients receiving probiotics and compare the the gut microbiome with moderate premature infants not receiving probiotics. In addition, we are including a control of healthy full-term infants.\n\nSamples containing feces from participants will be analyzed by state of the art whole-genome sequencing techniques. Bacterial diversity and taxonomy will be analysed using bioinformatic tools\n\nInclusion criteria:\n\n* Preterm infants 24-27 weeks gestation/ birth weight \\< 1000 g receiving probiotics\n* Preterm infants 28-31 weeks gestation/BW 1000-1500 g not receiving probiotics\n* Healthy term infants\n\nExclusion criteria\n\n* Preterm infants \\< 24 weeks gestation\n* Preterm infants \\< 32 weeks with severe lethal complication/poor prognosis around 1 week of age\n* Infants with severe congenital malformations\n\nFecal samples will be obtained:\n\n* 1 week of age\n* 4 weeks of age\n* 4 months corrected age\n* 12 months corrected age\n\nStudy hypotheses:\n\n* Probiotics given to extremely preterm infants will change the biodiversity of the gut microflora.\n* Antibiotics given to these patients may influence the gut microflora also in infants receiving probiotics. In particular use of vancomycin may change the gut flora.\n* After cessation of probiotic prophylaxis the gut flora of infants receiving probiotics will gradually resemble the gut flora of infants not receiving probiotics.\n* A cross-contamination of probiotic bacteria between patients treated with probiotics and patients not treated with antibiotics may occur.\n\nThis is an explorative study. No formal sample size assessment is possible. Sequencing costs will be substantial. We will limit the number of participants to 26 x 2 preterm infants and 10 control healthy infants.\n\nSix Norwegian Neonatal Intensive care units wil participate in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'minimumAge': '1 Hour', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Preterm infants hospitalized in 6 Norwegian NICUs; divided in one group extremely preterm infants receiving probiotics and one group moderate preterm infants not receiving antibiotics. A group of helathy infants from the post-natal ward will also be included', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm infants with gestational age 24-27 weeks/birth weight \\< 1000 g, treated with probiotics (target number 26)\n* Preterm infants with gestational age 29-31 weeks/birth weight 1000-1500 g, not treated with probiotics (target number 26)\n* Term infants (target number 10)\n\nExclusion Criteria:\n\n* Extremely preterm infants with gestational age below 24 weeks\n* Preterm infants (24-31 weeks) with life threatening complications during 1 week of age\n* Infants with congenital malformations'}, 'identificationModule': {'nctId': 'NCT02197468', 'acronym': 'PINGU', 'briefTitle': 'Preterm Infant Gut (PINGU) - a Norwegian Multi Centre Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of North Norway'}, 'officialTitle': 'Gut Microbiome Study in Preterm Infants - a Norwegian Multi Centre Study', 'orgStudyIdInfo': {'id': '2014/930 (REK)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Probiotics', 'description': 'Preterm infants given probiotics: GA 24-27 weeks/Birth weight \\< 1000 g\n\nPreterm infants not given probiotics: GA 28-31 weeks/Birth weight 1000-1500 g\n\nFull-term infants not given probiotics (control)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5021', 'city': 'Bergen', 'country': 'Norway', 'facility': 'Haukeland Universtiy Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'zip': '0424', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital, Rikshospitalet', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': '0424', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital, Ullevaal', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Ahus University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': '4011', 'city': 'Stavanger', 'country': 'Norway', 'facility': 'Stavanger University Hospital', 'geoPoint': {'lat': 58.97005, 'lon': 5.73332}}, {'zip': '9038', 'city': 'Tromsø', 'country': 'Norway', 'facility': 'University Hospital of North Norway', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}, {'zip': '7030', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'St Olavs Hospital, Trondheim University Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Claus Klingenberg, MD.phD.Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital of North Norway'}, {'name': 'Eirin Esaiassen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of North-Noway'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of North Norway', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Tromso', 'class': 'OTHER'}, {'name': 'Oslo University Hospital', 'class': 'OTHER'}, {'name': 'Ullevaal University Hospital', 'class': 'OTHER'}, {'name': 'St. Olavs Hospital', 'class': 'OTHER'}, {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, {'name': 'Helse Stavanger HF', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}