Study of Yili Mei Yi Tian Active Lactobacillus Drink to Improve Immunity and Digestive System
Study on Evaluating the Promote Effect of Yili Mei Yi Tian Active Lactobacillus Drink on Immunity and Physical Intestinal Canal
1 other identifier
interventional
240
1 country
2
Brief Summary
Study on Evaluating the Promote Effect of Yili Mei Yi Tian Active Lactobacillus Drink on Immunity and Physical Intestinal Canal
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2011
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 23, 2012
CompletedFirst Posted
Study publicly available on registry
September 3, 2012
CompletedOctober 15, 2012
October 1, 2012
3 months
August 23, 2012
October 12, 2012
Conditions
Outcome Measures
Primary Outcomes (2)
Change in constipation condition
Baseline & 3 months
Assess severity of flu symptoms
3 months
Secondary Outcomes (2)
Change in immune markers such as antibodies and interleukins
Baseline & 3 months
Change in gut resident flora
Baseline & 3 months
Study Arms (2)
Yili "Mei Yi Tian" lactobacillus drink
ACTIVE COMPARATOR100ml 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 COMPARATOR100ml of recombined milk drink contains no lactobacillus to be taken once per day at 10am daily during the 84-days intervention
Interventions
100ml of Yili "Mei Yi Tian" active lactobacillus drink to be taken once per day at 10am daily during the 84-days intervention
100ml of recombined milk drink contains no lactobacillus to be taken once per day at 10am daily during the 84-days intervention
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
NanMoFang Community Health Service Center
ChaoYang District, Beijing Municipality, China
Shanghai Municipal Food and Drug Administration Baoshan Office
Baoshan District, Shanghai Municipality, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ying An, Ph.D
Inner Mongolia Hilo Industrial Group Co., Ltd
- PRINCIPAL INVESTIGATOR
Leiming Xu
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Digestive system Dept.
- PRINCIPAL INVESTIGATOR
Gengru Jiang
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Kidney Dept.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2012
First Posted
September 3, 2012
Study Start
August 1, 2011
Primary Completion
November 1, 2011
Study Completion
March 1, 2012
Last Updated
October 15, 2012
Record last verified: 2012-10