Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-31 @ 4:34 AM
Study NCT ID:
NCT03675204
Status:
COMPLETED
Last Update Posted:
2019-07-31
First Post:
2018-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establishment of the Breast Milk Database in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D061186', 'term': 'Breast Milk Expression'}], 'ancestors': [{'id': 'D001942', 'term': 'Breast Feeding'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'A minimum of 60ml of breast milk will be collected for each subject.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-29', 'studyFirstSubmitDate': '2018-09-05', 'studyFirstSubmitQcDate': '2018-09-16', 'lastUpdatePostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Protein in breast milk', 'timeFrame': 'At enrollment', 'description': 'Protein in breast milk measured in percent (%)'}], 'secondaryOutcomes': [{'measure': 'Osmotic pressure', 'timeFrame': 'At enrollment', 'description': 'Osmotic pressure (mmolOsm/Lkg.H2O) in breast milk'}, {'measure': 'Fatty acids in breast milk', 'timeFrame': 'At enrollment', 'description': 'Fatty acids composition (mg/L) in breast milk'}, {'measure': 'Amino acids', 'timeFrame': 'At enrollment', 'description': 'Amino acids composition (mg/L) in breast milk'}, {'measure': 'Oligosaccharides', 'timeFrame': 'At enrollment', 'description': 'Oligosaccharides levels (mg/L) in breast milk'}, {'measure': 'Probiotics', 'timeFrame': 'At enrollment', 'description': 'Probiotics composition (species) measured using gene sequencing in breast milk;'}, {'measure': 'Vitamins', 'timeFrame': 'At enrollment', 'description': 'Vitamins composition (μg/L) in breast milk'}, {'measure': 'Minerals', 'timeFrame': 'At enrollment', 'description': 'Minerals composition (mg/L) in breast milk'}, {'measure': 'Hormones', 'timeFrame': 'At enrollment', 'description': 'Hormones composition (mg/L) in breast milk'}, {'measure': 'Dietary composition of participating mothers', 'timeFrame': 'At enrollment', 'description': 'Investigation on the dietary composition of participating mothers obtained using questionnaire'}, {'measure': 'Height of participating mothers', 'timeFrame': 'At enrollment', 'description': 'Height measurement (cm) of participating mothers'}, {'measure': 'Weight of participating mothers', 'timeFrame': 'At enrollment', 'description': 'Body weight measurement (kg) of participating mothers'}, {'measure': 'Age of participating mothers', 'timeFrame': 'At enrollment', 'description': 'Age (years) of participating mothers obtained using questionnaire'}, {'measure': 'Educational level of participating mothers', 'timeFrame': 'At enrollment', 'description': 'Educational level of participating mothers obtained using questionnaire'}, {'measure': 'Occupation of participating mothers', 'timeFrame': 'At enrollment', 'description': 'Occupation of participating mothers obtained using questionnaire'}, {'measure': 'Physical health condition of participating mothers', 'timeFrame': 'At enrollment', 'description': 'Physical health condition of participating mothers assessed by questionnaire'}, {'measure': 'Triglyceride', 'timeFrame': 'At enrollment', 'description': 'Triglyceride (mg/g) contents in breast milk'}, {'measure': 'Phospholipid', 'timeFrame': 'At enrollment', 'description': 'Phospholipid (mg/g) contents in breast milk'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Milk Collection']}, 'descriptionModule': {'briefSummary': 'Collect breast milk samples in various administrative regions of China to measure the nutrients in breast milk; analyze the composition of nutrients; and establish the database of breast milk in China.', 'detailedDescription': 'The study cities are Guangzhou, Weihai, Chengdu, Beijing, Harbin, Wuhan, Jinhua, Zhengzhou and Lanzhou.\n\nBreast milk will be collected at 9:00-11:00 in the morning from 15 to180 days after giving birth. The nutrients (protein, triglyceride, phospholipid, oligosaccharides and probiotics) in the collected breast milk samples will be measured. These data will be used to establish the breast milk database in China. This databased will provide references for infant nutrient intake and for the formulation and revision of infant formula standards. It will also provide references for the development of new infant formula products in China.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy lactating mother of 25 \\~ 35 years old who are currently breast-feeding infants of 15 \\~180 days old. Subjects are equally distributed in the postpartum time period of 15\\~35 days, 36\\~65 days, 66\\~95 days, 96\\~125 days, 126\\~55 days and 156\\~185 days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lactating mother 25 \\~ 35 years old;\n* Breast-feeding infants (15 \\~180 days old );\n* Physically healthy by self-evaluation;\n* Does not smoke;\n* Does not drink alcohol;\n* Have given birth to physically healthy infants;\n* Signed the informed consent forms.\n\nExclusion Criteria:\n\n* Being treated for gastrointestinal symptoms;\n* Suffering from mastitis;\n* Suffering from infectious diseases (tuberculosis, viral hepatitis and HIV infection);\n* Suffering from cardiovascular disease;\n* Suffering from metabolic diseases (such as diabetes);\n* Suffering from mental system diseases;\n* Suffering from cancer and other malignant diseases;\n* Having history of taking antibiotics;\n* Not able to answer the study questions;\n* Participating in any nutritional or pharmaceutical intervention study recently.'}, 'identificationModule': {'nctId': 'NCT03675204', 'briefTitle': 'Establishment of the Breast Milk Database in China', 'organization': {'class': 'INDUSTRY', 'fullName': 'Heilongjiang Feihe Dairy Co. Ltd.'}, 'officialTitle': 'Establishment of the Breast Milk Database in China', 'orgStudyIdInfo': {'id': '16-SC-05-FC-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Shilong Jiang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Heilongjiang Feihe Dairy Co. Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heilongjiang Feihe Dairy Co. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}