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Completed

NCT Number: NCT01677702

Study 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.

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Key information

Age range

6 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NanMoFang Community Health Service Center, Chao Yang District, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Dietary Supplement

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)

Dietary Supplement

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

Dietary Supplement

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

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

Sponsors and collaborators

Lead sponsor

Inner Mongolia Yili Industrial Group Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Sep 3, 2012
Registry last updated
Oct 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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