EUCTR2011-003089-34-DE进行中（未招募）不适用
The effect for 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 with six weeks intervention
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,058
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Men or women in a general good state of health
- •2. Age 18-60 years both inclusive
- •3. BMI 19-30 kg/m2
- •4. Provided voluntary written informed consent
- •Subjects are eligible for randomization if they fulfill the following two criteria during the run-in period:
- •5. Has not taken any antibiotics during the run-in period.
- •6. Has been able to abstain from fermented dairy products (such as yoghurts) as well as foods and food
- •supplements containing probiotics during the run-in period. Single violations will be allowed.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1058
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Chronic immunological diseases such as known HIV infection, rheumatoid arthritis, multiple sclerosis,
- •diabetes requiring insulin treatment, asthma, allergy, eczema, inflammatory bowel disease, crohn’s
- •disease, thyroid diseases. Subjects with chronic diseases and conditions with no potential impact on
- •the primary endpoint are not excluded provided they have been adequately controlled with
- •concomitant medication for at least three months. Subjects with hay fever may also be enrolled
- •outside the pollen season
- •2. No cancers within the past five years with the exception of carcinoma in situ and basal-cell
- •3. Influenza vaccination current season or has already suffered from influenza during the current
- •4. Acute disease requiring treatment
- •5. Use of immunosuppressant medication except locally acting glucocorticoids within one month prior
- •to the screening visit
- •6. Lactose intolerance or milk protein allergy
- •7. Hypersensitivity to any of the components of the vaccine
- •8. Recent (6 months) complicated gastrointestinal (GI) surgery that may have an impact on GI tract
- •9. Oral antibiotics within one month prior to the screening visit, or within four months prior to the
- •screening visit if given for a recurrent condition
- •10. Elite athletes with intensive physical activity more than two hours/day (i.e. 14 hour/week)
- •11. Participation in another clinical trial within the past month
- •12. For women: pregnant or lactating, or wish to be pregnant during the study
- •13. For women: not willing to use reliable contraceptive methods. In Germany the following methods
- •are allowed: hormonal contraceptives (oral or implants), tubal ligation, intrauterine device, condoms
- •or sexual abstinence. In Denmark the following methods are allowed: hormonal contraceptives (oral
- •or implants), tubal ligation, intrauterine device or double barrier. Women must use reliable methods
- •from screening until after the final study visit..
- •14. Known allergy or systemic allergy-like hypersensitivity to chicken protein, irrespective of the severity of the previous symptoms or of the contact route to the allergen.
研究者
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