CTRI/2018/05/013813
Completed
未知
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 sites250 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ITC Life Sciences and Technology Center
- Enrollment
- 250
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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