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Completed

NCT Number: NCT01677715

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

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

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Key information

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NanMoFang Community Health Service Center, ChaoYang District, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yili "Mei Yi Tian" active lactobacillus drink

Dietary Supplement

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

Dietary Supplement

100ml of recombined milk drink contains no lactobacillus to be taken once per day at 10am daily during the 84-days intervention

Primary outcomes

  1. Change in constipation condition

    Time frame: Baseline & 3 months

  2. Assess severity of flu symptoms

    Time frame: 3 months

Secondary outcomes

  1. Change in immune markers such as antibodies and interleukins

    Time frame: Baseline & 3 months

  2. Change in gut resident flora

    Time frame: Baseline & 3 months

Sponsors and collaborators

Lead sponsor

Inner Mongolia Yili Industrial Group Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Sep 3, 2012
Registry last updated
Oct 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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