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

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

Study Overview

• Status: Completed
• Conditions: Dyspepsia; Abdominal Pain; Constipation; Flatulence; Common Cold; Human Influenza; Immunization
• Intervention / Treatment: Dietary supplement: Yili "Mei Yi Tian" active lactobacillus drink; Dietary supplement: recombined milk drink contains no lactobacillus

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • ChaoYang District, Beijing, China
      • NanMoFang Community Health Service Center
  • Shanghai
    • Baoshan District, Shanghai, China
      • Shanghai Municipal Food and Drug Administration Baoshan Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Dietary supplement: 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
Placebo Comparator: 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	Dietary supplement: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Inner Mongolia Yili Industrial Group Co., Ltd
• Investigators: 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 record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: August 23, 2012
• First Submitted That Met QC Criteria: August 29, 2012
• First Posted (Estimate): September 3, 2012

Study Record Updates

• Last Update Posted (Estimate): October 15, 2012
• Last Update Submitted That Met QC Criteria: October 12, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Picornaviridae Infections; Orthomyxoviridae Infections; Dyspepsia; Abdominal Pain; Influenza, Human; Constipation; Common Cold; Flatulence
• Other Study ID Numbers: YL/CL-003