Study of Yili Mei Yi Tian Active Lactobacillus Drink to Improve Immunity and Digestive System
NCT ID: NCT01677715
Last Updated: 2012-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
240 participants
INTERVENTIONAL
2011-08-31
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Yili "Mei Yi Tian" lactobacillus drink
100ml of Yili "Mei Yi Tian" active lactobacillus drink to be taken once per day at 10am daily during the 84-days intervention
Yili "Mei Yi Tian" active lactobacillus drink
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 lactobacillus
100ml of recombined milk drink contains no lactobacillus to be taken once per day at 10am daily during the 84-days intervention
recombined milk drink contains no lactobacillus
100ml of recombined milk drink contains no lactobacillus to be taken once per day at 10am daily during the 84-days intervention
Interventions
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Yili "Mei Yi Tian" active lactobacillus drink
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 lactobacillus
100ml of recombined milk drink contains no lactobacillus to be taken once per day at 10am daily during the 84-days intervention
Eligibility Criteria
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Inclusion Criteria
* 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 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
25 Years
45 Years
ALL
Yes
Sponsors
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Inner Mongolia Yili Industrial Group Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Ying An, Ph.D
Role: STUDY_DIRECTOR
Inner Mongolia Hilo Industrial Group Co., Ltd
Leiming Xu
Role: PRINCIPAL_INVESTIGATOR
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Digestive system Dept.
Gengru Jiang
Role: PRINCIPAL_INVESTIGATOR
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Kidney Dept.
Locations
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NanMoFang Community Health Service Center
ChaoYang District, Beijing Municipality, China
Shanghai Municipal Food and Drug Administration Baoshan Office
Baoshan District, Shanghai Municipality, China
Countries
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Other Identifiers
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YL/CL-003
Identifier Type: -
Identifier Source: org_study_id