Phase 2 Study to check the Effectiveness & Safety of Probiotics in Healthy people
- Registration Number
- CTRI/2023/01/048913
- Lead Sponsor
- Advanced Enzymes Technologies Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1) Male/female healthy individuals aged 18-65 years at the time of consent. 2) Individuals who are literate and who are willing to give voluntary written informed consent.
1) History of consumption of drugs or dietary or probiotic supplements related to immune function within two weeks prior to screening;
2) Known case of hypersensitivity to the study product;
3) Known case of hypertension, diabetes mellitus; any
history/presence of significant metabolic or autoimmune disease
4) History/presence of acute or chronic disorders of cardiac, liver, kidney, or gastrointestinal system within last 6 months from screening;
5) History/presence of any other acute or chronic disease requiring treatment condition, in the opinion of the investigator, which could jeopardize the study outcome;
6) Females who are breast-feeding/ pregnant, or intend to become
pregnant during the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method