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

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

Study Overview

• Status: Completed
• Conditions: Common Cold; Human Influenza; Immunization
• Intervention / Treatment: Dietary supplement: Yili Lactoferrin ShuHua Milk (Lactoferrin 5mg/100ml); Dietary supplement: Yili Lactoferrin ShuHua Milk (Lactoferrin 10mg/100ml); Dietary supplement: Recombined low protein milk

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Chao Yang District, Beijing, China
      • NanMoFang Community Health Service Center
  • Shanghai
    • GuCun, Baoshan District,, Shanghai, China
      • JuQuan Community Health Service Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 73 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Active Comparator: 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.	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.
Placebo Comparator: Recombined low-protein milk; Total 250mL placebo milk will be taken once per day at 10am daily during the 84 days intervention.	Dietary supplement: Recombined low protein milk; Total 250ml of placebo milk will be taken once a day at 10am daily during the 84 day intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assess occurrence of flu symptoms during intervention	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Inner Mongolia Yili Industrial Group Co., Ltd
• Investigators: Principal Investigator: Yeqing Shi, Changhai Hospital of Shanghai, Rheumatology Dept.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: August 23, 2012
• First Submitted That Met QC Criteria: August 29, 2012
• First Posted (Estimate): September 3, 2012

Study Record Updates

• Last Update Posted (Estimate): October 25, 2012
• Last Update Submitted That Met QC Criteria: October 24, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Picornaviridae Infections; Orthomyxoviridae Infections; Influenza, Human; Common Cold; Anti-Infective Agents; Lactoferrin
• Other Study ID Numbers: YL/CL-002