Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-25 @ 6:52 PM
Study NCT ID:
NCT01677702
Status:
COMPLETED
Last Update Posted:
2012-10-25
First Post:
2012-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Yili Lactoferrin ShuHua Milk in the Improvement of Human Immunization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D003139', 'term': 'Common Cold'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007781', 'term': 'Lactoferrin'}], 'ancestors': [{'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D061250', 'term': 'Transferrins'}, {'id': 'D033862', 'term': 'Iron-Binding Proteins'}, {'id': 'D002352', 'term': 'Carrier Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007782', 'term': 'Lactoglobulins'}, {'id': 'D000067816', 'term': 'Whey Proteins'}, {'id': 'D008894', 'term': 'Milk Proteins'}, {'id': 'D000080224', 'term': 'Animal Proteins, Dietary'}, {'id': 'D004044', 'term': 'Dietary Proteins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D008667', 'term': 'Metalloproteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-24', 'studyFirstSubmitDate': '2012-08-23', 'studyFirstSubmitQcDate': '2012-08-29', 'lastUpdatePostDateStruct': {'date': '2012-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess occurrence of flu symptoms during intervention', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Assess severity of flu symptoms', 'timeFrame': '3 months'}, {'measure': 'Proportion of subjects which require treatment with flu medication', 'timeFrame': '3 months'}, {'measure': 'Change in immune markers such as antibodies and interleukins', 'timeFrame': 'Baseline & 3 months'}, {'measure': 'Record subject sick leave due to flu', 'timeFrame': '3 months'}]}, 'conditionsModule': {'conditions': ['Immunization', 'Human Influenza', 'Common Cold']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Yili Lactoferrin ShuHua Milk are effective in reducing the occurrence of flu symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 6 to 12 years, catch cold for 4 to 6 times in last year;\n* Age 35 to 45 years, catch cold for 4 to 6 times in recent 3 month;\n* Age 60 to 75 years, catch cold for 4 to 6 times in last year;\n* BMI 18.5to 29.9kg/m2;\n* Able to understand the nature and purpose of the study including potential risks and side effects\n\nExclusion Criteria:\n\n* Recent (within 6 months of screening) been vaccinated influenza vaccine, or recent (within 15 days of screening) been vaccinated ther vaccines;\n* Suffering from rhinitis chronic, laryngitis, labored breathing that similar to flu symptoms. Such as chronic allergic rhinitis, asthma, COPD;\n* Long-term use of any prescription or OTC medication that inhibit or prevent flu symptoms, including but not limited to, antihistamine, pectoral, high doses of vitamin C;\n* Recent use (within 3 months of screening) of any prescription or OTC medication that significantly affects immune response, such as antibiotic;\n* Known allergies to dairy and any substance in the study product;\n* History of alcohol, drug, or medication abuse\n* Pregnant or breastfeeding women\n* Recent daily use (within 3 months of screening) of any probiotics, clabber or yogurt;\n* Any comorbidity that could, in the opinion of the investigator, preclude the subject's ability to successfully and safely complete the study or that may confound study outcomes"}, 'identificationModule': {'nctId': 'NCT01677702', 'briefTitle': 'Study of Yili Lactoferrin ShuHua Milk in the Improvement of Human Immunization', 'organization': {'class': 'INDUSTRY', 'fullName': 'Inner Mongolia Yili Industrial Group Co., Ltd'}, 'officialTitle': 'The Clinical Research on the Efficiency of Yili Lactoferrin Shuhua Milk in the Improvement of Human Immunization', 'orgStudyIdInfo': {'id': 'YL/CL-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Yili Lactoferrin ShuHua Milk (lactoferrin 5mg/100ml)', 'description': 'Total 250mL milk (with lactoferrin 5mg/100ml) will be taken once per day at 10am daily during the 84 days intervention.', 'interventionNames': ['Dietary Supplement: Yili Lactoferrin ShuHua Milk (Lactoferrin 5mg/100ml)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Yili Lactoferrin ShuHua Milk (lactoferrin 10mg/100ml)', 'description': 'Total 250mL milk (with lactoferrin 10mg/100ml) will be taken once per day at 10am daily during the 84 days intervention.', 'interventionNames': ['Dietary Supplement: Yili Lactoferrin ShuHua Milk (Lactoferrin 10mg/100ml)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Recombined low-protein milk', 'description': 'Total 250mL placebo milk will be taken once per day at 10am daily during the 84 days intervention.', 'interventionNames': ['Dietary Supplement: Recombined low protein milk']}], 'interventions': [{'name': 'Yili Lactoferrin ShuHua Milk (Lactoferrin 5mg/100ml)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Total 250mL milk (with lactoferrin 5mg/100ml) will be taken once per day at 10am daily during the 84 days intervention.', 'armGroupLabels': ['Yili Lactoferrin ShuHua Milk (lactoferrin 5mg/100ml)']}, {'name': 'Yili Lactoferrin ShuHua Milk (Lactoferrin 10mg/100ml)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Total 250mL milk (with lactoferrin 10mg/100ml) will be taken once per day at 10am daily during the 84 days intervention.', 'armGroupLabels': ['Yili Lactoferrin ShuHua Milk (lactoferrin 10mg/100ml)']}, {'name': 'Recombined low protein milk', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Total 250ml of placebo milk will be taken once a day at 10am daily during the 84 day intervention.', 'armGroupLabels': ['Recombined low-protein milk']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chao Yang District', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'NanMoFang Community Health Service Center'}, {'city': 'GuCun, Baoshan District,', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'JuQuan Community Health Service Center', 'geoPoint': {'lat': 31.34933, 'lon': 121.39341}}], 'overallOfficials': [{'name': 'Ying An, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Inner Mongolia Hilo Industrial Group Co., Ltd'}, {'name': 'Donglian Cai', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changhai Hospital of Shanghai, Nutriology Dept.'}, {'name': 'Yeqing Shi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changhai Hospital of Shanghai, Rheumatology Dept.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inner Mongolia Yili Industrial Group Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}