Clinical trial NCT01677702: Study of Yili Lactoferrin ShuHua Milk in the Improvement of Human Immunization
Official title: The Clinical Research on the Efficiency of Yili Lactoferrin Shuhua Milk in the Improvement of Human Immunization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunization
Human Influenza
Common Cold
Lead sponsor: Inner Mongolia Yili Industrial Group Co., Ltd
Sponsor class: INDUSTRY
First posted: 2012-09-03
Enrollment: 240
Sex: ALL
Minimum age (years): 6
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether Yili Lactoferrin ShuHua Milk are effective in reducing the occurrence of flu symptoms.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Assess occurrence of flu symptoms during intervention
timeFrame: 3 months
Secondary outcomes:
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
Other outcomes:
Locations:
city: Chao Yang District
country: China
facility: NanMoFang Community Health Service Center
state: Beijing
city: GuCun, Baoshan District,
country: China
facility: JuQuan Community Health Service Center
state: Shanghai
Study officials:
affiliation: Inner Mongolia Hilo Industrial Group Co., Ltd
name: Ying An, Ph.D
role: STUDY_DIRECTOR
affiliation: Changhai Hospital of Shanghai, Nutriology Dept.
name: Donglian Cai
role: PRINCIPAL_INVESTIGATOR
affiliation: Changhai Hospital of Shanghai, Rheumatology Dept.
name: Yeqing Shi
role: PRINCIPAL_INVESTIGATOR
References: