Study of Yili Lactoferrin ShuHua Milk in the Improvement of Human Immunization
The Clinical Research on the Efficiency of Yili Lactoferrin Shuhua Milk in the Improvement of Human Immunization
1 other identifier
interventional
240
1 country
2
Brief Summary
The purpose of this study is to determine whether Yili Lactoferrin ShuHua Milk are effective in reducing the occurrence of flu symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2011
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 23, 2012
CompletedFirst Posted
Study publicly available on registry
September 3, 2012
CompletedOctober 25, 2012
October 1, 2012
4 months
August 23, 2012
October 24, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Assess occurrence of flu symptoms during intervention
3 months
Secondary Outcomes (4)
Assess severity of flu symptoms
3 months
Proportion of subjects which require treatment with flu medication
3 months
Change in immune markers such as antibodies and interleukins
Baseline & 3 months
Record subject sick leave due to flu
3 months
Study Arms (3)
Yili Lactoferrin ShuHua Milk (lactoferrin 5mg/100ml)
ACTIVE COMPARATORTotal 250mL milk (with lactoferrin 5mg/100ml) will be taken once per day at 10am daily during the 84 days intervention.
Yili Lactoferrin ShuHua Milk (lactoferrin 10mg/100ml)
ACTIVE COMPARATORTotal 250mL milk (with lactoferrin 10mg/100ml) will be taken once per day at 10am daily during the 84 days intervention.
Recombined low-protein milk
PLACEBO COMPARATORTotal 250mL placebo milk will be taken once per day at 10am daily during the 84 days intervention.
Interventions
Total 250mL milk (with lactoferrin 5mg/100ml) will be taken once per day at 10am daily during the 84 days intervention.
Total 250mL milk (with lactoferrin 10mg/100ml) will be taken once per day at 10am daily during the 84 days intervention.
Total 250ml of placebo milk will be taken once a day at 10am daily during the 84 day intervention.
Eligibility Criteria
You may qualify if:
- Age 6 to 12 years, catch cold for 4 to 6 times in last year;
- Age 35 to 45 years, catch cold for 4 to 6 times in recent 3 month;
- Age 60 to 75 years, catch cold for 4 to 6 times in last year;
- BMI 18.5to 29.9kg/m2;
- Able to understand the nature and purpose of the study including potential risks and side effects
You may not qualify if:
- Recent (within 6 months of screening) been vaccinated influenza vaccine, or recent (within 15 days of screening) been vaccinated ther vaccines;
- Suffering from rhinitis chronic, laryngitis, labored breathing that similar to flu symptoms. Such as chronic allergic rhinitis, asthma, COPD;
- 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;
- Recent use (within 3 months of screening) of any prescription or OTC medication that significantly affects immune response, such as antibiotic;
- Known allergies to dairy and any substance in the study product;
- History of alcohol, drug, or medication abuse
- Pregnant or breastfeeding women
- Recent daily use (within 3 months of screening) of any probiotics, clabber or yogurt;
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
NanMoFang Community Health Service Center
Chao Yang District, Beijing Municipality, China
JuQuan Community Health Service Center
GuCun, Baoshan District,, Shanghai Municipality, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ying An, Ph.D
Inner Mongolia Hilo Industrial Group Co., Ltd
- PRINCIPAL INVESTIGATOR
Donglian Cai
Changhai Hospital of Shanghai, Nutriology Dept.
- PRINCIPAL INVESTIGATOR
Yeqing Shi
Changhai Hospital of Shanghai, Rheumatology Dept.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2012
First Posted
September 3, 2012
Study Start
March 1, 2011
Primary Completion
July 1, 2011
Study Completion
October 1, 2011
Last Updated
October 25, 2012
Record last verified: 2012-10