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

I

Inner Mongolia Yili Industrial Group

Status

Completed

Conditions

Flatulence
Human Influenza
Immunization
Dyspepsia
Constipation
Common Cold
Abdominal Pain

Treatments

Dietary Supplement: recombined milk drink contains no lactobacillus
Dietary Supplement: Yili "Mei Yi Tian" active lactobacillus drink

Study type

Interventional

Funder types

Industry

Identifiers

NCT01677715
YL/CL-003

Details and patient eligibility

About

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

Enrollment

240 patients

Sex

All

Ages

25 to 45 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

240 participants in 2 patient groups, including a placebo group

Yili "Mei Yi Tian" lactobacillus drink
Active Comparator group
Description:
100ml of Yili "Mei Yi Tian" active lactobacillus drink to be taken once per day at 10am daily during the 84-days intervention
Treatment:
Dietary Supplement: Yili "Mei Yi Tian" active lactobacillus drink
recombined milk drink contains no lactobacillus
Placebo Comparator group
Description:
100ml of recombined milk drink contains no lactobacillus to be taken once per day at 10am daily during the 84-days intervention
Treatment:
Dietary Supplement: recombined milk drink contains no lactobacillus

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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