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

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01677715
• Other study ID #: YL/CL-003
• Status: Completed
• Phase: N/A
• First received: August 23, 2012
• Last updated: October 12, 2012
• Start date: August 2011
• Est. completion date: March 2012

Study information

• Verified date: October 2012
• Source: Inner Mongolia Yili Industrial Group Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: March 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 45 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Abdominal Pain
• Common Cold
• Constipation
• Dyspepsia
• Flatulence
• Human Influenza
• Immunization
• Influenza, Human

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
• 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

Locations

Country	Name	City	State
China	Shanghai Municipal Food and Drug Administration Baoshan Office	Baoshan District	Shanghai
China	NanMoFang Community Health Service Center	ChaoYang District	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Inner Mongolia Yili Industrial Group Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in constipation condition		Baseline & 3 months	No
Primary	Assess severity of flu symptoms		3 months	No
Secondary	Change in immune markers such as antibodies and interleukins		Baseline & 3 months	No
Secondary	Change in gut resident flora		Baseline & 3 months	No