ImmunizationNCT01677702
Study of Yili Lactoferrin ShuHua Milk in the Improvement of Human Immunization
A study testing Yili Lactoferrin ShuHua Milk (Lactoferrin 5mg/100ml), Yili Lactoferrin ShuHua Milk (Lactoferrin 10mg/100ml) and Recombined low protein milk in people with Immunization and Human Influenza, run by Inner Mongolia Yili Industrial Group Co., Ltd at 2 sites in China.
Trial summary
The purpose of this study is to determine whether Yili Lactoferrin ShuHua Milk are effective in reducing the occurrence of flu symptoms. Read more about this study
- Who is it for?
- Ages 6 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunization, Human Influenza, Common Cold
- What is being tested?
- Yili Lactoferrin ShuHua Milk (Lactoferrin 5mg/100ml), Yili Lactoferrin ShuHua Milk (Lactoferrin 10mg/100ml) and Recombined low protein milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 2 sitesChina
- Study dates
- Mar 2011to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
NanMoFang Community Health Service Center
Chao Yang District, Beijing Municipality
JuQuan Community Health Service Center
GuCun, Baoshan District,, Shanghai Municipality
About this study
Official title: The Clinical Research on the Efficiency 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.
- Conditions
- Immunization, Human Influenza, Common Cold
- Being tested
- Yili Lactoferrin ShuHua Milk (Lactoferrin 5mg/100ml), Yili Lactoferrin ShuHua Milk (Lactoferrin 10mg/100ml), Recombined low protein milk
- Medical subject headings
- Influenza, Human, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 milkDietary supplement
Total 250ml of placebo milk will be taken once a day at 10am daily during the 84 day intervention.
| Study group | Role | What they receive |
|---|---|---|
| Yili Lactoferrin ShuHua Milk (lactoferrin 5mg/100ml) | Active comparator | Total 250mL milk (with lactoferrin 5mg/100ml) will be taken once per day at 10am daily during the 84 days intervention. Receives: Dietary Supplement: Yili Lactoferrin ShuHua Milk (Lactoferrin 5mg/100ml) |
| Yili Lactoferrin ShuHua Milk (lactoferrin 10mg/100ml) | Active comparator | Total 250mL milk (with lactoferrin 10mg/100ml) will be taken once per day at 10am daily during the 84 days intervention. Receives: Dietary Supplement: Yili Lactoferrin ShuHua Milk (Lactoferrin 10mg/100ml) |
| Recombined low-protein milk | Placebo comparator | Total 250mL placebo milk will be taken once per day at 10am daily during the 84 days intervention. Receives: Dietary Supplement: Recombined low protein milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess occurrence of flu symptoms during intervention
Measured: 3 months
Secondary outcomes (4)
Assess severity of flu symptoms
Measured: 3 months
Proportion of subjects which require treatment with flu medication
Measured: 3 months
Change in immune markers such as antibodies and interleukins
Measured: Baseline & 3 months
Record subject sick leave due to flu
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study startMar 2011
- Primary completionJul 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inner Mongolia Yili Industrial Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ying An, Ph.D, Study director, Inner Mongolia Hilo Industrial Group Co., LtdDonglian Cai, Principal investigator, Changhai Hospital of Shanghai, Nutriology Dept.Yeqing Shi, Principal investigator, Changhai Hospital of Shanghai, Rheumatology Dept.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677702
- Sponsor's protocol ID
- YL/CL-002
- Status last verified
- Oct 2012
- First submitted
- 23 Aug 2012
- Last updated
- 25 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Research on the Efficiency of Yili Lactoferrin Shuhua Milk in the Improvement of Human Immunization
- ClinicalTrials.gov ID
- NCT01677702
- Acronym / sponsor ID
- YL/CL-002
- Conditions
- Immunization, Human Influenza, Common Cold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Inner Mongolia Yili Industrial Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 3 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Yili Lactoferrin ShuHua Milk are effective in reducing the occurrence of flu symptoms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Yili Lactoferrin ShuHua Milk (lactoferrin 5mg/100ml) | Active comparator | 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) | Active comparator | 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. |
| Recombined low-protein milk | Placebo comparator | Dietary Supplement: Recombined low protein milkTotal 250mL placebo milk will be taken once per day at 10am daily during the 84 days intervention. |
Who may qualify
- Ages
- 6 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) |
| 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) |
| Recombined low protein milkTotal 250ml of placebo milk will be taken once a day at 10am daily during the 84 day intervention. | Dietary supplement | Recombined low-protein milk |
Primary outcome
Assess occurrence of flu symptoms during intervention
Time frame: 3 months
4 secondary outcomes
Assess severity of flu symptoms
Time frame: 3 months
Proportion of subjects which require treatment with flu medication
Time frame: 3 months
Change in immune markers such as antibodies and interleukins
Time frame: Baseline & 3 months
Record subject sick leave due to flu
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yili Lactoferrin ShuHua Milk (Lactoferrin 5mg/100ml), Yili Lactoferrin ShuHua Milk (Lactoferrin 10mg/100ml) and Recombined low protein milk in people with Immunization and Human Influenza, run by Inner Mongolia Yili Industrial Group Co., Ltd at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess occurrence of flu symptoms during intervention (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2012.