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

Primary Purpose

Immunization, Human Influenza, Common Cold

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Yili "Mei Yi Tian" active lactobacillus drink
recombined milk drink contains no lactobacillus
Sponsored by
Inner Mongolia Yili Industrial Group Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Immunization

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • NanMoFang Community Health Service Center
  • Shanghai Municipal Food and Drug Administration Baoshan Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Yili "Mei Yi Tian" lactobacillus drink

recombined milk drink contains no lactobacillus

Arm Description

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

Outcomes

Primary Outcome Measures

Change in constipation condition
Assess severity of flu symptoms

Secondary Outcome Measures

Change in immune markers such as antibodies and interleukins
Change in gut resident flora

Full Information

First Posted
August 23, 2012
Last Updated
October 12, 2012
Sponsor
Inner Mongolia Yili Industrial Group Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01677715
Brief Title
Study of Yili Mei Yi Tian Active Lactobacillus Drink to Improve Immunity and Digestive System
Official Title
Study on Evaluating the Promote Effect of Yili Mei Yi Tian Active Lactobacillus Drink on Immunity and Physical Intestinal Canal
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inner Mongolia Yili Industrial Group Co., Ltd

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunization, Human Influenza, Common Cold, Constipation, Dyspepsia, Flatulence, Abdominal Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yili "Mei Yi Tian" lactobacillus drink
Arm Type
Active Comparator
Arm Description
100ml of Yili "Mei Yi Tian" active lactobacillus drink to be taken once per day at 10am daily during the 84-days intervention
Arm Title
recombined milk drink contains no lactobacillus
Arm Type
Placebo Comparator
Arm Description
100ml of recombined milk drink contains no lactobacillus to be taken once per day at 10am daily during the 84-days intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Yili "Mei Yi Tian" active lactobacillus drink
Intervention Description
100ml of Yili "Mei Yi Tian" active lactobacillus drink to be taken once per day at 10am daily during the 84-days intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
recombined milk drink contains no lactobacillus
Intervention Description
100ml of recombined milk drink contains no lactobacillus to be taken once per day at 10am daily during the 84-days intervention
Primary Outcome Measure Information:
Title
Change in constipation condition
Time Frame
Baseline & 3 months
Title
Assess severity of flu symptoms
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in immune markers such as antibodies and interleukins
Time Frame
Baseline & 3 months
Title
Change in gut resident flora
Time Frame
Baseline & 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying An, Ph.D
Organizational Affiliation
Inner Mongolia Hilo Industrial Group Co., Ltd
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Leiming Xu
Organizational Affiliation
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Digestive system Dept.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gengru Jiang
Organizational Affiliation
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Kidney Dept.
Official's Role
Principal Investigator
Facility Information:
Facility Name
NanMoFang Community Health Service Center
City
ChaoYang District
State/Province
Beijing
Country
China
Facility Name
Shanghai Municipal Food and Drug Administration Baoshan Office
City
Baoshan District
State/Province
Shanghai
Country
China

12. IPD Sharing Statement

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

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