Study of Yili Mei Yi Tian Active Lactobacillus Drink to Improve Immunity and Digestive System

Study Overview
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Brief Summary
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Study on Evaluating the Promote Effect of Yili Mei Yi Tian Active Lactobacillus Drink on Immunity and Physical Intestinal Canal

Official Title
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Study on Evaluating the Promote Effect of Yili Mei Yi Tian Active Lactobacillus Drink on Immunity and Physical Intestinal Canal

Conditions
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Immunization, Human Influenza, Common Cold, Constipation, Dyspepsia, Flatulence, Abdominal Pain

Intervention / Treatment
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* Dietary Supplement: Yili Mei Yi Tian active lactobacillus drink
* Dietary Supplement: recombined milk drink contains no lactobacillus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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; 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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Yili Mei Yi Tian lactobacillus drink<br>100ml 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 active lactobacillus drink<br>* 100ml of Yili Mei Yi Tian active lactobacillus drink to be taken once per day at 10am daily during the 84-days intervention<br>|
| Placebo Comparator: recombined milk drink contains no lactobacillus<br>100ml 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<br>* 100ml of recombined milk drink contains no lactobacillus to be taken once per day at 10am daily during the 84-days intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in constipation condition |  | Baseline & 3 months | 
| Assess severity of flu symptoms |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in immune markers such as antibodies and interleukins |  | Baseline & 3 months | 
| Change in gut resident flora |  | Baseline & 3 months |