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CompletedNCT01677702Updated Oct 25, 2012

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

An interventional study of Yili Lactoferrin ShuHua Milk (Lactoferrin 5mg/100ml) and Yili Lactoferrin ShuHua Milk (Lactoferrin 10mg/100ml) in Immunization, Human Influenza and Common Cold, sponsored by Inner Mongolia Yili Industrial Group Co., Ltd. Completed at 2 sites in China. Open to participants aged 6 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-10-25.

Sponsored by Inner Mongolia Yili Industrial Group Co., Ltd · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
6 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Immunization
  • Human Influenza
  • Common Cold
03

In context

Common Cold

180 studies on the registry are indexed under Common Cold; 22 are open to participants now.

This study's enrollment of 240 is above the median of 167 across 151 interventional studies indexed under Common Cold.

Browse Common Cold studies →

Lead sponsor

Inner Mongolia Yili Industrial Group Co., Ltd is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
240 participants (actual)

Study arms

  • 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)

  • 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)

  • 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

Interventions

  • Dietary supplementYili 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 supplementYili 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 supplementRecombined low protein milk

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

06

What researchers measure

Primary outcomes

  1. Assess occurrence of flu symptoms during intervention

    Time frame: 3 months

Secondary outcomes

  1. Assess severity of flu symptoms

    Time frame: 3 months

  2. Proportion of subjects which require treatment with flu medication

    Time frame: 3 months

  3. Change in immune markers such as antibodies and interleukins

    Time frame: Baseline & 3 months

  4. Record subject sick leave due to flu

    Time frame: 3 months

07

Study locations

2 sites
  • NanMoFang Community Health Service Center
    Chao Yang District, Beijing, China
  • JuQuan Community Health Service Center
    GuCun, Baoshan District,, Shanghai, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01677702
Lead sponsor
Inner Mongolia Yili Industrial Group Co., Ltd
Responsible party
Sponsor
First posted
Sep 3, 2012
Start date
Mar 2011
Primary completion
Jul 2011
Completion
Oct 2011
Last update
Oct 25, 2012

Study contacts

Ying An, Ph.D
study director · Inner Mongolia Hilo Industrial Group Co., Ltd
Donglian Cai
principal investigator · Changhai Hospital of Shanghai, Nutriology Dept.
Yeqing Shi
principal investigator · Changhai Hospital of Shanghai, Rheumatology Dept.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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