Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-03-28 @ 2:19 PM
Study NCT ID:
NCT02470104
Status:
COMPLETED
Last Update Posted:
2020-08-20
First Post:
2015-04-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Donor Human Milk in Young Children Receiving Bone Marrow Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-18', 'studyFirstSubmitDate': '2015-04-01', 'studyFirstSubmitQcDate': '2015-06-10', 'lastUpdatePostDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of lactobacillales', 'timeFrame': '21 days after transplant', 'description': 'Bar chart to indicate percentage of lactobacillales in stool samples.'}], 'secondaryOutcomes': [{'measure': 'Pro-inflammatory cytokine level', 'timeFrame': 'weekly during study course; up to approximately one year', 'description': 'Mean fold increase above baseline for the cytokine will be calculated and compared to control. Value will be tested for statistical significance using the Wilcoxon Rank Sum test.'}, {'measure': 'Incidence of bacteremia', 'timeFrame': 'though day 14 post transplant', 'description': 'Frequency of bacterial sepsis to be compared against controls.'}, {'measure': 'Incidence of graft versus host disease (GVHD)', 'timeFrame': 'through study course; approximately one year', 'description': 'Frequency of GVHD will be compared to controls.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['children', 'bone marrow transplant', 'autologous', 'allogeneic', 'breastmilk', 'hematopoietic stem cell transplantation (HSCT)'], 'conditions': ['Bone Marrow Transplant - Autologous or Allogeneic']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that children receiving human milk will maintain a greater diversity of helpful bacteria in their gut and have lower levels of inflammatory proteins in the blood compared with children not receiving human milk.', 'detailedDescription': 'The investigators hypothesize that the gut microbiota during bone marrow transplant could be influenced by administration of enteral donor breast milk. This study will attempt to address this hypothesis, by feeding donor breast milk to young children undergoing transplant, and serially comparing the gut microbiota in children receiving human milk, with those receiving conventional feeding.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children less than 5 years old receiving transplant (autologous or allogeneic)\n* Parents must give informed consent\n\nExclusion Criteria:\n\n* Failure to meet inclusion criteria'}, 'identificationModule': {'nctId': 'NCT02470104', 'briefTitle': 'Donor Human Milk in Young Children Receiving Bone Marrow Transplantation', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'A Randomized Study of Enteral Donor Human Milk in Young Children Receiving Bone Marrow Transplantation', 'orgStudyIdInfo': {'id': '2014-4127'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enteral Donor Breastmilk', 'description': '* Donor milk will be pasteurized prior to use.\n* Given orally or by nasogastric (NG) or nasojejunal (NJ) tube.\n* Feeding will be supervised and will be advanced as quickly as tolerated with a goal of providing 40-50% of nutritional needs from the donor milk.\n* It is recognized that the volume of enteral feeds will need to be adjusted per patient tolerance.', 'interventionNames': ['Dietary Supplement: Breastmilk']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': '• Children randomized to the control arm will receive standard enteral or parenteral nutrition per standard clinical practice, supervised by a registered dietician.'}], 'interventions': [{'name': 'Breastmilk', 'type': 'DIETARY_SUPPLEMENT', 'description': '* A registered dietician will supervise milk provision.\n* If a nursing mother enrolls on the study, maternal and not donor milk will be given in the maximum volume possible with Prolacta supplementation if clinically indicated and recommended by the registered dietician.', 'armGroupLabels': ['Enteral Donor Breastmilk']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Stella Davies, MB.BS, PhD, MRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'collaborators': [{'name': 'Prolacta Bioscience', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}