Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 5:59 AM
Study NCT ID:
NCT00810160
Status:
COMPLETED
Last Update Posted:
2017-07-13
First Post:
2008-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Oligosaccharides and Bifidobacteria on the Intestinal Microflora of Premature Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C586340', 'term': 'bificin C6165, Bifidobacterium animalis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-11', 'studyFirstSubmitDate': '2008-12-15', 'studyFirstSubmitQcDate': '2008-12-15', 'lastUpdatePostDateStruct': {'date': '2017-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the optimum dose and optimum dietary supplement to promote a fecal microflora in the formula fed premature infant that is similar to that of the term breast fed infant (a predominance of bifidobacteria).', 'timeFrame': 'six weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['probiotic', 'prebiotic', 'oligosaccharides', 'GOS', 'galacto oligosaccharides', 'Bifidobacterium infantis', 'Bifidobacterium animalis'], 'conditions': ['Fecal Microflora in the Formula Fed Premature Infant']}, 'referencesModule': {'references': [{'pmid': '23993139', 'type': 'DERIVED', 'citation': 'Underwood MA, Kalanetra KM, Bokulich NA, Lewis ZT, Mirmiran M, Tancredi DJ, Mills DA. A comparison of two probiotic strains of bifidobacteria in premature infants. J Pediatr. 2013 Dec;163(6):1585-1591.e9. doi: 10.1016/j.jpeds.2013.07.017. Epub 2013 Aug 29.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see whether dietary supplements can change the germs in the intestines of premature infants to be more like those of healthy breast fed term babies.', 'detailedDescription': 'To determine the optimum dose and optimum dietary supplement to promote a fecal microflora in the formula fed premature infant that is similar to that of the term breast fed infant (a predominance of bifidobacteria). In the initial phase of this trial, 30 premature infants will be randomly assigned to receive increasing doses of one of four dietary supplements: Permeate (a pasteurized human milk concentrate containing human milk oligosaccharides processed by Prolacta), GOS (galacto-oligosaccharides manufactured by Friesland foods), Bifidobacterium infantis or Bifidobacterium animalis. Weekly stool specimens will be examined by PCR to determine content of bifidobacteria and total bacteria. This study is limited to formula fed infants in order to avoid the confounding effects of the human milk oligosaccharides in breast milk. An additional 12 human milk fed infants will be enrolled and will have their diet supplemented with ProlactPlus (a pasteurized human milk concentrate containing humna milk oligosaccharides) or powdered human milk fortifier for comparison'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Born in or transferred to UCDMC within the first two weeks of life. Birth weight less than 1500 grams. Gestational age less than 33 completed weeks. Exclusively formula fed.\n\nExclusion Criteria:\n\n* Gastrointestinal or cardiac anomalies.'}, 'identificationModule': {'nctId': 'NCT00810160', 'briefTitle': 'The Impact of Oligosaccharides and Bifidobacteria on the Intestinal Microflora of Premature Infants', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Phase 1A Study of Impact of Oligosaccharides and Bifidobacteria on the Intestinal Microflora of Premature Infants', 'orgStudyIdInfo': {'id': '243213'}, 'secondaryIdInfos': [{'id': 'R01HD059127', 'link': 'https://reporter.nih.gov/quickSearch/R01HD059127', 'type': 'NIH'}, {'id': 'HD059127-01', 'type': 'OTHER', 'domain': 'UC Davis'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Permeate', 'interventionNames': ['Dietary Supplement: ProlactPlus']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'GOS', 'interventionNames': ['Dietary Supplement: GOS galacto-oligosaccharides']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Bifidobacterium infantis', 'interventionNames': ['Dietary Supplement: Bifidobacterium infantis']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'description': 'Bifidobacterium animalis', 'interventionNames': ['Dietary Supplement: Bifidobacterium animalis']}], 'interventions': [{'name': 'ProlactPlus', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['human milk oligosaccharides'], 'description': 'Group 1 infants will be fed a concentration of Permeate mixed with formula. The ProlactPlus will be increased each week as follows: week 1 95:5 (formula:ProlactPlus), week 2 90:10, week 3 85:15, week 4 80:20, and week 5 75:25. Caloric content is roughly as follows: week 1 21 cal/oz, week 2 22 cal/oz, week 3 23 cal/oz, week 4 24 cal/oz, and week 5 25 cal/oz.', 'armGroupLabels': ['1']}, {'name': 'GOS galacto-oligosaccharides', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['galacto-oligosaccharides'], 'description': 'Group 2 infants will have their formula supplemented with galacto-oligosaccharides (GOS) for each feeding as follows: week 1 0.25 g/dL, week 2 0.5 g/dL, week 3 1.0 g/dL, week 4 1.5 g/dL, and week 5 2.0 g/dL.', 'armGroupLabels': ['2']}, {'name': 'Bifidobacterium infantis', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['bifidobacteria', 'B. infantis'], 'description': 'Group 3 infants will have their formula supplemented with B. infantis twice daily increasing the dose each week as follows: week 1 5x107, week 2 1.5x108, week 3 4.5x108, week 4 1.4x109, and week 5 4.2x109.', 'armGroupLabels': ['3']}, {'name': 'Bifidobacterium animalis', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['B. animalis', 'bifidobacteria'], 'description': 'Group 4 infants will have their formula supplemented with B. animalis twice daily increasing the dose each week as follows: week 1 5x107, week 2 1.5x108, week 3 4.5x108, week 4 1.4x109, and week 5 4.2x109.', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Mark Underwood, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}