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

Not Applicable

Completed

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

• Registration Number: NCT01677715
• Lead Sponsor: Inner Mongolia Yili Industrial Group Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2011-11
• Study Completion: 2012-03
• Study First Submitted: 2012-08-23
• Study First Submitted QC: 2012-08-29
• Study First Posted: 2012-09-03
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-12
• Last Update Posted: 2012-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yili "Mei Yi Tian" lactobacillus drink	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
recombined milk drink contains no lactobacillus	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

Primary Outcome Measures

Name	Time	Method
Change in constipation condition	Baseline & 3 months
Assess severity of flu symptoms	3 months

Secondary Outcome Measures

Name	Time	Method
Change in immune markers such as antibodies and interleukins	Baseline & 3 months
Change in gut resident flora	Baseline & 3 months

Trial Locations

Locations (2)

Shanghai Municipal Food and Drug Administration Baoshan Office; 🇨🇳 Baoshan District, Shanghai, China

NanMoFang Community Health Service Center; 🇨🇳 ChaoYang District, Beijing, China