NL-OMON51589已完成不适用
Change in markers of immune function associated with Bacillus subtilis CU1 intervention in different age groups - BSCU1 and immune function
Gnosis by Lesaffre0 个研究点目标入组 90 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 99（—）
入选标准
- •Substantial
- •30 <= age <= 49 years
- •BMI >= 18.5 and <=25 kg/m2
- •In good health as assessed during screening (by questionnaire), and the
- •medical investigator*s professional judgment
- •Non-smoking
- •Substantial
- •65 <= age <= 79 years
- •BMI 22.0 - 28.0 kg/m2
- •Generally healthy as assessed during screening (by questionnaire), and the
- •medical investigator*s professional judgment
- •Non-smoking
- •Procedural (both for adults and elderly):
- •Ability to follow Dutch verbal and written instructions
- •Signed informed consent
- •Willingness to give up blood donation during the entire study
- •Substantial
- •3 <= age <= 6 years
- •Healthy BMI, cut-off points will be used as indicated by JGZ (BMI jongens en
- •meisjes | Voedingscentrum)
- •Generally healthy as assessed during screening (by parental anamnesis), and
- •the study physician*s professional judgment
- •Procedural:
- •Parents/caretakers having the ability to follow Dutch verbal and written
- •instructions
- •Signed informed consent
排除标准
- •Adults and elderly
- •Substantial
- •Chronic illness (e.g., diabetes mellitus, cardiac insufficiency, respiratory
- •insufficiency, cancer, chronic kidney or liver disease),
- •Acute infection in the past month
- •Gastrointestinal disorders (e.g., inflammatory bowel disease),
- •Acute gastroenteritis in the past 2 months
- •Any vaccination in the past month
- •Treatment with antibiotics within 2 months of the start of the study,
- •Regular use of laxative agents
- •Immunodeficiency disorder
- •Use of immunosuppressive drugs (e.g.cyclosporine, azathioprine, systemic
- •corticosteroids, antibodies)
- •Unexplained weight loss or weight gain of > 3 kg in the 3 months prior to
- •pre-study screening
- •Regular consumption of probiotics within 1 month before start of the study
- •Evidence of current excessive alcohol consumption (>4 consumptions/day or >20
- •consumptions/week) or drug (ab)use
- •Mental status that is incompatible with the proper conduct of the study
- •Procedural:
- •Not having a general practitioner, not allowing disclosure of participation
- •to the general practitioner or not allow to inform the general practitioner
- •about abnormal results. Participation in any clinical trial including
- •blood sampling and/or administration of substances starting 1 month prior
- •to study start and during the entire study.
- •Personnel of NIZO or Gnosis by Lesaffre, their partner and their first and
- •second degree relatives.
- •Substantial
- •Acute respiratory or gastrointestinal or chronic infections
- •Chronic systemic or metabolic diseases
- •Gastrointestinal disorders (e.g., inflammatory bowel disease),
- •Acute gastroenteritis in the past 2 months
- •Any vaccination in the past month
- •Treatment with antibiotics within 2 months of the start of the study,
- •Immunodeficiency disorder
- •Use of anti-inflammatory or immunosuppressive drugs (e.g.cyclosporine,
- •azathioprine, systemic corticosteroids, antibodies)
- •Regular use of laxative agents
- •Regular consumption of probiotic supplements within 1 month before start of
- •Procedural:
- •Parents or caretakers not having a general practitioner, not allowing
- •disclosure of participation to the general practitioner or not allowing to
- •inform the general practitioner about abnormal results.
- •Participation in any clinical trial starting 1 month prior to study
- •start and during the entire study.
- •Parents who are personnel of NIZO or Gnosis by Lesaffre, their partner and
- •their first and second degree relatives.
研究者
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