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

Sponsor

Inner Mongolia Yili Industrial Group Co., Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT01677715

Collaborator

(none)

240

Enrollment

Locations

Arms

Duration (Months)

120

Patients Per Site

17.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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

Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in constipation condition [Baseline & 3 months]
Assess severity of flu symptoms [3 months]

Secondary Outcome Measures

Change in immune markers such as antibodies and interleukins [Baseline & 3 months]
Change in gut resident flora [Baseline & 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	NanMoFang Community Health Service Center	ChaoYang District	Beijing	China
2	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.