A double blind, randomized, prospective clinical trial to evaluate efficacy and safety of a formulation on gut immunity of healthy subjects

ITC Life Sciences and Technology Center0 个研究点目标入组 250 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Healthy subjects both male and female (non-pregnant female) gender. {As defined by medical history and physical examination}
•2.Age groups: Group A- Children:8 to 13 years, Group B Adults: 18-60 years.
•3.Parents or Legal Guardian willing to give consent for age Group B: 8-13 years.
•4.Participants of age group 18 â?? 60 years willing to give consent.
•5.Participants willing to avoid fermented foods throughout the study duration.
•6.No regular use of fibre supplementation over the month prior to the screening visit
•7.The subject must be able to comply with study procedures in the opinion of the investigator.

•1.Any gross gastrointestinal pathology.
•2.Allergy or intolerance to lactose or any other food ingredient.
•3.Suffering from any chronic neuroendocrine or metabolic disorders.
•4.Major gastro-intestinal surgery in last 6 month
•5.Have consumed prebiotics and/or probiotics, drugs that affect gastrointestinal mobility.
•6.Pregnant and lactating women.
•7.Drug and/or alcohol abuse.
•8.Participation in another study with any investigational product within 3 months of screening.
•9.Any other recent illness that may compromise the immune system.

发起方

ITC Life Sciences and Technology Center