CTRI/2019/01/017256已完成未知
To Evaluate the effect of Yakult® on the Immune System of Late Middle-aged Indian Adults.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 30
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
入选标准
- •1.Resident of KEMHRC, Vadu HDSS area
- •2.Healthy men and women, Age between 51-60 years on the day of enrollment
- •3.Consented to participate.
- •4.Participantsâ?? willingness and ability to comply with the requirements of the protocol.
排除标准
- •1.Study participants currently enrolled in other interventional trial
- •2.Inability to comply with the study protocol
- •3.Shift or late-night workers
- •4.Known/reported allergy or hypersensitivity to any medicines and foods (also including allergy against dairy products)
- •5.Known/reported severe chronic disease (e.g. cancer, malabsorption, physician ascertained malnutrition, severe chronic infection and infestation, renal, hepatic or cardiac diseases, artificial cardiac valve, COPD (chronic obstructive pulmonary disease), respiratory insufficiency)
- •6.History of any cancer, HIV infection, organ transplant or any other immune system disorder
- •7.Acute illness (moderate or severe) and/or fever (axillary temperature >= 38°C or 100.4°F) at the time of enrollment or during the 7 days prior to the enrollment. (TE)
- •8.Known congenital, acquired or iatrogenic immunodeficiency (e.g. HIV, chemotherapy, immunosuppression) or on immune suppressive drugs (within last six months)
- •9.Chronic administration (defined as more than 14 days in total) of immunosuppressant or other immune modifying drugs during the period starting six months prior to the enrollment. However, inhaled or topical steroids are allowed.
- •10.Known/reported severe neurological, cognitive or psychiatric diseases
- •11.Presence of acute/chronic stress (assessed as per the stress questionnaires)
- •12.Known/reported eating disorders (e.g. anorexia, bulimia)
- •13.Reported alcohol consumption with frequency more than once in a week and regular consumption of drug
- •14.Regular medical treatment including over the counter (OTC), which may have impact on the study aims (e.g. probiotics, laxatives etc.)
- •15.Receipt of any oral or injectable antibiotics 5 days before enrollment. (TE)
- •16.Study participants who are scheduled to undergo hospitalization during the study period
- •17.History of receipt of a blood transfusion, other blood products, or immune-globulins in month prior to enrollment.
- •18.Participant has any plans to permanently relocate from the area prior to the completion of the study or to leave for an extended period of time when study visits would need to be scheduled
- •19.Pregnant and lactating women
- •20.Any condition which the investigator considers sufficiently serious to interfere with the conduct of the trial or that constitutes any risk to the participants
研究者
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