The effect of Lactobacillus paracasei subsp. paracasei, L. casei 431® on immune response to influenza vaccination in healthy adult volunteers: a multi-center, randomized, placebo-controlled, parallel-group study

Chr. Hansen A/S (Denmark)0 个研究点目标入组 1,058 人开始时间: 2011年9月28日最近更新: 2016年10月17日

试验速览

暂无简介。

•1. Men or women in a general good state of health, age 18-60 years both inclusive
•2. Body mass index (BMI) 19-30 kg/m2
•3. Provided voluntary written informed consent
•4. No antibiotics during the run-in period
•5. Subject has been able to abstain from fermented dairy products (such as yoghurts) as well as food and food supplements containing probiotics during the run-in period

•1. Chronic immunological disease
•2. No cancers within the past five years
•3. Influenza vaccination current season or has already suffered from influenza during the current season
•4. Acute disease requiring treatment
•5. Use of immunosuppressant medication
•6. Lactose intolerance or milk protein allergy
•7. Hypersensitivity to any of the components of the vaccine
•8. Recent complicated gastrointestinal (GI) surgery that may have an impact on GI tract function
•9. Oral antibiotics within one month prior to the screening visit
•10. Elite athletes
•11. Participation in another clinical trial within the past month
•12. For pre-menopausal women: pregnant or lactating, or wish to be pregnant during the study and not willing to use reliable contraceptive methods

发起方

Chr. Hansen A/S (Denmark)