Study of Yili Lactoferrin ShuHua Milk in the Improvement of Human Immunization

Common Cold Clinical Trial

Official title:

The Clinical Research on the Efficiency of Yili Lactoferrin Shuhua Milk in the Improvement of Human Immunization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01677702
• Other study ID #: YL/CL-002
• Status: Completed
• Phase: N/A
• First received: August 23, 2012
• Last updated: October 24, 2012
• Start date: March 2011
• Est. completion date: October 2011

Study information

• Verified date: October 2012
• Source: Inner Mongolia Yili Industrial Group Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: October 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Common Cold
• Human Influenza
• Immunization
• Influenza, Human

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.
• 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
Total 250ml of placebo milk will be taken once a day at 10am daily during the 84 day intervention.

Locations

Country	Name	City	State
China	NanMoFang Community Health Service Center	Chao Yang District	Beijing
China	JuQuan Community Health Service Center	GuCun, Baoshan District,	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Inner Mongolia Yili Industrial Group Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess occurrence of flu symptoms during intervention		3 months	No
Secondary	Assess severity of flu symptoms		3 months	No
Secondary	Proportion of subjects which require treatment with flu medication		3 months	No
Secondary	Change in immune markers such as antibodies and interleukins		Baseline & 3 months	No
Secondary	Record subject sick leave due to flu		3 months	No