The Clinical Research on the Efficiency of Yili Lactoferrin Shuhua Milk in the Improvement of Human Immunization
| Registry | NCT01677702 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, prevention |
| Enrollment | 240 (Actual) |
| Sponsor | Inner Mongolia Yili Industrial Group Co., Ltd (Industry) |
| Conditions | Immunization, Human Influenza, Common Cold |
| Interventions | Yili Lactoferrin ShuHua Milk (Lactoferrin 5mg/100ml), Yili Lactoferrin ShuHua Milk (Lactoferrin 10mg/100ml), Recombined low protein milk (Dietary supplement) |
| Dates | start 2011-03-01, primary completion 2011-07-01, completion 2011-10-01, first posted 2012-09-03, last updated 2012-10-25 |
| Locations | 2 sites in China |
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Immunization All trials for Human Influenza All trials of Yili Lactoferrin ShuHua Milk (Lactoferrin 5mg/100ml) All trials of Yili Lactoferrin ShuHua Milk (Lactoferrin 10mg/100ml)
The purpose of this study is to determine whether Yili Lactoferrin ShuHua Milk are effective in reducing the occurrence of flu symptoms.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Yili Lactoferrin ShuHua Milk (lactoferrin 5mg/100ml) | Active comparator | Dietary Supplement: Yili Lactoferrin ShuHua Milk (Lactoferrin 5mg/100ml) | Total 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 comparator | Dietary Supplement: Yili Lactoferrin ShuHua Milk (Lactoferrin 10mg/100ml) | Total 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 comparator | Dietary Supplement: Recombined low protein milk | Total 250mL placebo milk will be taken once per day at 10am daily during the 84 days intervention. |
Sex: All, ages: 6 Years to 75 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| NanMoFang Community Health Service Center | Chao Yang District, Beijing Municipality | China | |
| JuQuan Community Health Service Center | GuCun, Baoshan District,, Shanghai Municipality | China |