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

Primary Purpose

Immunization, Human Influenza, Common Cold

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Yili Lactoferrin ShuHua Milk (Lactoferrin 5mg/100ml)
Yili Lactoferrin ShuHua Milk (Lactoferrin 10mg/100ml)
Recombined low protein milk
Sponsored by
Inner Mongolia Yili Industrial Group Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Immunization

Eligibility Criteria

6 Years - 75 Years (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • NanMoFang Community Health Service Center
  • JuQuan Community Health Service Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Yili Lactoferrin ShuHua Milk (lactoferrin 5mg/100ml)

Yili Lactoferrin ShuHua Milk (lactoferrin 10mg/100ml)

Recombined low-protein milk

Arm Description

Total 250mL milk (with lactoferrin 5mg/100ml) will be taken once per day at 10am daily during the 84 days intervention.

Total 250mL milk (with lactoferrin 10mg/100ml) will be taken once per day at 10am daily during the 84 days intervention.

Total 250mL placebo milk will be taken once per day at 10am daily during the 84 days intervention.

Outcomes

Primary Outcome Measures

Assess occurrence of flu symptoms during intervention

Secondary Outcome Measures

Assess severity of flu symptoms
Proportion of subjects which require treatment with flu medication
Change in immune markers such as antibodies and interleukins
Record subject sick leave due to flu

Full Information

First Posted
August 23, 2012
Last Updated
October 24, 2012
Sponsor
Inner Mongolia Yili Industrial Group Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01677702
Brief Title
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

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inner Mongolia Yili Industrial Group Co., Ltd

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunization, Human Influenza, Common Cold

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yili Lactoferrin ShuHua Milk (lactoferrin 5mg/100ml)
Arm Type
Active Comparator
Arm Description
Total 250mL milk (with lactoferrin 5mg/100ml) will be taken once per day at 10am daily during the 84 days intervention.
Arm Title
Yili Lactoferrin ShuHua Milk (lactoferrin 10mg/100ml)
Arm Type
Active Comparator
Arm Description
Total 250mL milk (with lactoferrin 10mg/100ml) will be taken once per day at 10am daily during the 84 days intervention.
Arm Title
Recombined low-protein milk
Arm Type
Placebo Comparator
Arm Description
Total 250mL placebo milk will be taken once per day at 10am daily during the 84 days intervention.
Intervention Type
Dietary Supplement
Intervention Name(s)
Yili Lactoferrin ShuHua Milk (Lactoferrin 5mg/100ml)
Intervention Description
Total 250mL milk (with lactoferrin 5mg/100ml) will be taken once per day at 10am daily during the 84 days intervention.
Intervention Type
Dietary Supplement
Intervention Name(s)
Yili Lactoferrin ShuHua Milk (Lactoferrin 10mg/100ml)
Intervention Description
Total 250mL milk (with lactoferrin 10mg/100ml) will be taken once per day at 10am daily during the 84 days intervention.
Intervention Type
Dietary Supplement
Intervention Name(s)
Recombined low protein milk
Intervention Description
Total 250ml of placebo milk will be taken once a day at 10am daily during the 84 day intervention.
Primary Outcome Measure Information:
Title
Assess occurrence of flu symptoms during intervention
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Assess severity of flu symptoms
Time Frame
3 months
Title
Proportion of subjects which require treatment with flu medication
Time Frame
3 months
Title
Change in immune markers such as antibodies and interleukins
Time Frame
Baseline & 3 months
Title
Record subject sick leave due to flu
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying An, Ph.D
Organizational Affiliation
Inner Mongolia Hilo Industrial Group Co., Ltd
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Donglian Cai
Organizational Affiliation
Changhai Hospital of Shanghai, Nutriology Dept.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yeqing Shi
Organizational Affiliation
Changhai Hospital of Shanghai, Rheumatology Dept.
Official's Role
Principal Investigator
Facility Information:
Facility Name
NanMoFang Community Health Service Center
City
Chao Yang District
State/Province
Beijing
Country
China
Facility Name
JuQuan Community Health Service Center
City
GuCun, Baoshan District,
State/Province
Shanghai
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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