A study to see the effect of supplementation with probiotics on Immunity levels.
- Registration Number
- CTRI/2024/01/061336
- Lead Sponsor
- Sanzyme Biologics P Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
clinically stable elderly subjects of either gender in the age group of 60 to 65 years in general good health but susceptible to cold or cough or fever during seasonal changes throughout the year
1.Any Chronic diseases like Hypertension, Diabetes, Coronary Artery Disease, Rheumatoid Arthritis OR any chronic illness.
2.Active dependency on controlled substances and alcohol,
3.Not willing to sign the Informed Consent Form
4.Administration of an investigational drug either currently or within 30 days of screening.
5.Active addictive drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements or assessment.
6.Any illness or condition that in the opinion of the investigator may affect the safety of the participant or the evaluation of any study endpoint.
7.Significant preexisting cardiac or pulmonary or hepatic or neurological co-morbidities
8.Patients with social conditions or medical debilitating disease or disorder, which, in the judgment of the investigator, would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent or affect overall prognosis of the patient.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •To evaluate the NK Cell cytolytic activity (NK cell activity assay) and Proportion of volunteers showing change in NK cell activity as a marker of Immunity in adult subjects at Baseline and at the end of the treatment of 12 weeks with Bacillus coagulans SNZ 1969. <br/ ><br>•To evaluate the absolute number and percentage of NK cells as measured by CD16 CD56 positive cells at Baseline and at the end of the treatment of 12 weeks with Bacillus coagulans SNZ 1969. <br/ ><br>•Improvement of Immunoglobulin levels (Serum Ig M, Serum Ig G, Salivary Ig A) at the end of 12 weeks supplementation. <br/ ><br>Timepoint: Baseline and 12 weeks after treatment
- Secondary Outcome Measures
Name Time Method •Reduction in occurrence (Incidence <br/ ><br> and Duration) of gastrointestinal infections and respiratory infections. <br/ ><br>•Reduction in total number of days of illness OR the number of emergency medical visits. <br/ ><br>•Reduction in serious infections necessitating antibiotic use. <br/ ><br>•Reduction in CRP levels (marker of inflammation) <br/ ><br>Timepoint: Baseline and 12 weeks after treatment