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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Inner Mongolia Yili Industrial Group Co., Ltd
ClinicalTrials.gov Identifier:
NCT01677702
First received: August 23, 2012
Last updated: October 24, 2012
Last verified: October 2012
History of Changes
  Purpose

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


Condition Intervention
Immunization
Human Influenza
Common Cold
 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
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: The Clinical Research on the Efficiency of Yili Lactoferrin Shuhua Milk in the Improvement of Human Immunization

Resource links provided by NLM:

MedlinePlus related topics: Common Cold Flu
U.S. FDA Resources

Further study details as provided by Inner Mongolia Yili Industrial Group Co., Ltd:

Primary Outcome Measures:
  • Assess occurrence of flu symptoms during intervention [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess severity of flu symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Proportion of subjects which require treatment with flu medication [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Change in immune markers such as antibodies and interleukins [ Time Frame: Baseline & 3 months ] [ Designated as safety issue: No ]
  • Record subject sick leave due to flu [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 240
Study Start Date: March 2011
Study Completion Date: October 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   6 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01677702

Locations
China, Beijing
NanMoFang Community Health Service Center
Chao Yang District, Beijing, China
China, Shanghai
JuQuan Community Health Service Center
GuCun, Baoshan District,, Shanghai, China
Sponsors and Collaborators
Inner Mongolia Yili Industrial Group Co., Ltd
Investigators
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.
  More Information

No publications provided

Responsible Party: Inner Mongolia Yili Industrial Group Co., Ltd
ClinicalTrials.gov Identifier: NCT01677702     History of Changes
Other Study ID Numbers: YL/CL-002
Study First Received: August 23, 2012
Last Updated: October 24, 2012
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Common Cold
Influenza, Human
Picornaviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Orthomyxoviridae Infections

ClinicalTrials.gov processed this record on June 17, 2013