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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Inner Mongolia Yili Industrial Group Co., Ltd
ClinicalTrials.gov Identifier:
NCT01677715
First received: August 23, 2012
Last updated: October 12, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention
Immunization
Human Influenza
Common Cold
Constipation
Dyspepsia
Flatulence
Abdominal Pain
Dietary Supplement: Yili "Mei Yi Tian" active lactobacillus drink
Dietary Supplement: recombined milk drink contains no lactobacillus

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Study on Evaluating the Promote Effect of Yili Mei Yi Tian Active Lactobacillus Drink on Immunity and Physical Intestinal Canal

Resource links provided by NLM:


Further study details as provided by Inner Mongolia Yili Industrial Group Co., Ltd:

Primary Outcome Measures:
  • Change in constipation condition [ Time Frame: Baseline & 3 months ] [ Designated as safety issue: No ]
  • Assess severity of flu symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in immune markers such as antibodies and interleukins [ Time Frame: Baseline & 3 months ] [ Designated as safety issue: No ]
  • Change in gut resident flora [ Time Frame: Baseline & 3 months ] [ Designated as safety issue: No ]

Enrollment: 240
Study Start Date: August 2011
Study Completion Date: March 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   25 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01677715

Locations
China, Beijing
NanMoFang Community Health Service Center
ChaoYang District, Beijing, China
China, Shanghai
Shanghai Municipal Food and Drug Administration Baoshan Office
Baoshan District, Shanghai, China
Sponsors and Collaborators
Inner Mongolia Yili Industrial Group Co., Ltd
Investigators
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.
  More Information

No publications provided

Responsible Party: Inner Mongolia Yili Industrial Group Co., Ltd
ClinicalTrials.gov Identifier: NCT01677715     History of Changes
Other Study ID Numbers: YL/CL-003
Study First Received: August 23, 2012
Last Updated: October 12, 2012
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Constipation
Abdominal Pain
Common Cold
Influenza, Human
Flatulence
Signs and Symptoms, Digestive
Signs and Symptoms
Pain
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Orthomyxoviridae Infections

ClinicalTrials.gov processed this record on October 16, 2014