Clinical trial NCT01677715: Study of Yili Mei Yi Tian Active Lactobacillus Drink to Improve Immunity and Digestive System
Official title: Study on Evaluating the Promote Effect of Yili Mei Yi Tian Active Lactobacillus Drink on Immunity and Physical Intestinal Canal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunization
Human Influenza
Common Cold
Constipation
Dyspepsia
Flatulence
Abdominal Pain
Lead sponsor: Inner Mongolia Yili Industrial Group Co., Ltd
Sponsor class: INDUSTRY
First posted: 2012-09-03
Enrollment: 240
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Change in constipation condition
timeFrame: Baseline & 3 months
measure: Assess severity of flu symptoms
timeFrame: 3 months
Secondary outcomes:
measure: Change in immune markers such as antibodies and interleukins
timeFrame: Baseline & 3 months
measure: Change in gut resident flora
timeFrame: Baseline & 3 months
Other outcomes:
Locations:
city: ChaoYang District
country: China
facility: NanMoFang Community Health Service Center
state: Beijing
city: Baoshan District
country: China
facility: Shanghai Municipal Food and Drug Administration Baoshan Office
state: Shanghai
Study officials:
affiliation: Inner Mongolia Hilo Industrial Group Co., Ltd
name: Ying An, Ph.D
role: STUDY_DIRECTOR
affiliation: Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Digestive system Dept.
name: Leiming Xu
role: PRINCIPAL_INVESTIGATOR
affiliation: Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Kidney Dept.
name: Gengru Jiang
role: PRINCIPAL_INVESTIGATOR
References: