ImmunizationNCT01677715
Study of Yili Mei Yi Tian Active Lactobacillus Drink to Improve Immunity and Digestive System
A study testing Yili "Mei Yi Tian" active lactobacillus drink and recombined milk drink contains no lactobacillus in people with Immunization and Human Influenza, run by Inner Mongolia Yili Industrial Group Co., Ltd at 2 sites in China.
Trial summary
Study on Evaluating the Promote Effect of Yili Mei Yi Tian Active Lactobacillus Drink on Immunity and Physical Intestinal Canal Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunization, Human Influenza, Common Cold
- What is being tested?
- Yili "Mei Yi Tian" active lactobacillus drink and recombined milk drink contains no lactobacillus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 2 sitesChina
- Study dates
- Aug 2011to Mar 2012
- 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 25 to 45 years sub-health white-collars, catch cold for 4 to 6 times in last year, with low immunity;
- Non-specific and/or moderate constipation;
- Irregular or occasional gastrointestinal disorders (flatulence, gurgling, feeling heavy after eating, abdominal pain);
- Slow transit or irregular bowels movements (abnormal feces solidity, bowel movements decreased, e.g. every 2-3 days or less than 3 times per week);
- Able to understand the nature and purpose of the study including potential risks and side effects;
- Willing to consent to study participation and to comply with study requirements
Who cannot join
- Diagnosed as immunity-low associated with chronic disease;
- Diagnosed as chronic constipation;
- Treated gastrointestinal symptoms;
- Currently suffering from diarrhea;
- Suffering from rhinitis chronic, laryngitis, labored breathing that similar to flu symptoms. Such as chronic allergic rhinitis, asthma, COPD;
- Treatment by analgesic such as aspirin and paracetamol;
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- Had laxatives or other remedies to promote digestion 2 weeks prior to the study start;
- Consuming dairy products or supplements containing pro/pre-biotic 10 days prior to the study start;
- 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;
- Recent inoculation (within 6 months of screening) of influenza vaccine, or other vaccine in 15 days;
- History of alcohol, drug, or medication abuse;
- Pregnant or breastfeeding women;
- Participation in another study with any investigational product within 3 months of screening
- 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
Shanghai Municipal Food and Drug Administration Baoshan Office
Baoshan District, Shanghai Municipality
NanMoFang Community Health Service Center
ChaoYang District, Beijing Municipality
About this study
Official title: Study on Evaluating the Promote Effect of Yili Mei Yi Tian Active Lactobacillus Drink on Immunity and Physical Intestinal Canal
Study on Evaluating the Promote Effect of Yili Mei Yi Tian Active Lactobacillus Drink on Immunity and Physical Intestinal Canal
- Conditions
- Immunization, Human Influenza, Common Cold, Constipation, Dyspepsia, Flatulence
- Being tested
- Yili "Mei Yi Tian" active lactobacillus drink, recombined milk drink contains no lactobacillus
- Medical subject headings
- Influenza, Human, Common Cold, Constipation, Dyspepsia, Flatulence, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yili "Mei Yi Tian" active lactobacillus drinkDietary supplement
100ml of Yili "Mei Yi Tian" active lactobacillus drink to be taken once per day at 10am daily during the 84-days intervention
recombined milk drink contains no lactobacillusDietary supplement
100ml of recombined milk drink contains no lactobacillus to be taken once per day at 10am daily during the 84-days intervention
| Study group | Role | What they receive |
|---|---|---|
| Yili "Mei Yi Tian" lactobacillus drink | Active comparator | 100ml of Yili "Mei Yi Tian" active lactobacillus drink to be taken once per day at 10am daily during the 84-days intervention Receives: Dietary Supplement: Yili "Mei Yi Tian" active lactobacillus drink |
| recombined milk drink contains no lactobacillus | Placebo comparator | 100ml of recombined milk drink contains no lactobacillus to be taken once per day at 10am daily during the 84-days intervention Receives: Dietary Supplement: recombined milk drink contains no lactobacillus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in constipation condition
Measured: Baseline & 3 months
Assess severity of flu symptoms
Measured: 3 months
Secondary outcomes (2)
Change in immune markers such as antibodies and interleukins
Measured: Baseline & 3 months
Change in gut resident flora
Measured: Baseline & 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 startAug 2011
- Primary completionNov 2011
- Study completionMar 2012
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., LtdLeiming Xu, Principal investigator, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Digestive system Dept.Gengru Jiang, Principal investigator, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Kidney Dept.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677715
- Sponsor's protocol ID
- YL/CL-003
- Status last verified
- Oct 2012
- First submitted
- 23 Aug 2012
- Last updated
- 15 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Evaluating the Promote Effect of Yili Mei Yi Tian Active Lactobacillus Drink on Immunity and Physical Intestinal Canal
- ClinicalTrials.gov ID
- NCT01677715
- Acronym / sponsor ID
- YL/CL-003
- Conditions
- Immunization, Human Influenza, Common Cold, Constipation, Dyspepsia, Flatulence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Inner Mongolia Yili Industrial Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Mar 2012 (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.
Study on Evaluating the Promote Effect of Yili Mei Yi Tian Active Lactobacillus Drink on Immunity and Physical Intestinal Canal
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yili "Mei Yi Tian" lactobacillus drink | Active comparator | Dietary Supplement: Yili "Mei Yi Tian" active lactobacillus drink100ml of Yili "Mei Yi Tian" active lactobacillus drink to be taken once per day at 10am daily during the 84-days intervention |
| recombined milk drink contains no lactobacillus | Placebo comparator | Dietary Supplement: recombined milk drink contains no lactobacillus100ml of recombined milk drink contains no lactobacillus to be taken once per day at 10am daily during the 84-days intervention |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 25 to 45 years sub-health white-collars, catch cold for 4 to 6 times in last year, with low immunity;
- Non-specific and/or moderate constipation;
- Irregular or occasional gastrointestinal disorders (flatulence, gurgling, feeling heavy after eating, abdominal pain);
- Slow transit or irregular bowels movements (abnormal feces solidity, bowel movements decreased, e.g. every 2-3 days or less than 3 times per week);
- Able to understand the nature and purpose of the study including potential risks and side effects;
Key exclusion criteria (15 listed)
- Diagnosed as immunity-low associated with chronic disease;
- Diagnosed as chronic constipation;
- Treated gastrointestinal symptoms;
- Currently suffering from diarrhea;
- Suffering from rhinitis chronic, laryngitis, labored breathing that similar to flu symptoms. Such as chronic allergic rhinitis, asthma, COPD;
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 "Mei Yi Tian" active lactobacillus drink100ml of Yili "Mei Yi Tian" active lactobacillus drink to be taken once per day at 10am daily during the 84-days intervention | Dietary supplement | Yili "Mei Yi Tian" lactobacillus drink |
| recombined milk drink contains no lactobacillus100ml of recombined milk drink contains no lactobacillus to be taken once per day at 10am daily during the 84-days intervention | Dietary supplement | recombined milk drink contains no lactobacillus |
Primary outcome
Change in constipation condition
Time frame: Baseline & 3 months
Assess severity of flu symptoms
Time frame: 3 months
2 secondary outcomes
Change in immune markers such as antibodies and interleukins
Time frame: Baseline & 3 months
Change in gut resident flora
Time frame: Baseline & 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 15 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
Leiming Xu principal investigator
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Digestive system Dept.
Gengru Jiang principal investigator
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Kidney 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 "Mei Yi Tian" active lactobacillus drink and recombined milk drink contains no lactobacillus 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 6 inclusion and 15 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 15 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?
Change in constipation condition (time frame: Baseline & 3 months). The study lists 2 primary outcomes in all. 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 15 Oct 2012.