A clinical study to assess the effect of a Bacillus coagulans-based product on immunomodulation and stress levels
Phase 4
- Registration Number
- CTRI/2023/01/048720
- Lead Sponsor
- Abode Biotec India Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Healthy male/female of age 18-65 years.
2.FBG (<= 126 mg/dl).
3.Normal blood parameters (Hb >= 10 g/dl).
4.Subjects who understand the nature and purpose of the study
Exclusion Criteria
1.Women who are pregnant or Lactating.
2.Subjects who are taking Antibiotic treatment
3.Subjects suffering from Gastrointestinal disease
4.Subjects suffering from Diabetes
5.Subjects suffering from Chronic/iatrogenic immunodeficiency
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effect on the systemic and adaptive immune system will be measured by change in ISQ score from baseline to eight weeks of treatment between the intervention group and the placebo groupTimepoint: 8 weeks
- Secondary Outcome Measures
Name Time Method 1.Differences in hematological parameters such as CBC in-between the 2 groups over the study period. <br/ ><br>2.Differences in Immune parameters such as Kidney Function, Liver Function IgG, IgM, IgA,Lipid Profile in-between the 2 groups over the study periodTimepoint: 8 weeks