A study to see the effect of supplementation with probiotics on Immunity levels.

A randomized, double blind, placebo-controlled study to evaluate the immunomodulatory role of Bacillus coagulans SNZ 1969 in adult subjects. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061336

Enrollment

Registered

2024-01-10

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Probiotic Bacillus coagulans SNZ 1969: Probiotic Bacillus coagulans SNZ 1969 NLT 2 Billion CFU in Capsule form administered once daily for 12 weeks. Control Intervention1: Placebo: Iden

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
•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. •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. •Improvement of Immunoglobulin levels (Serum Ig M, Serum Ig G, Salivary Ig A) at the end of 12 weeks supplementation. Timepoint: Baseline and 12 weeks after treatment	—

Measure

Time frame

•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. •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. •Improvement of Immunoglobulin levels (Serum Ig M, Serum Ig G, Salivary Ig A) at the end of 12 weeks supplementation. Timepoint: Baseline and 12 weeks after treatment

—

Secondary

Measure	Time frame
• Reduction in occurrence (Incidence and Duration) of gastrointestinal infections and respiratory infections. • Reduction in total number of days of illness OR the number of emergency medical visits. • Reduction in serious infections necessitating antibiotic use. • Reduction in CRP levels (marker of inflammation) Timepoint: Baseline and 12 weeks after treatment	—

Countries

India

Contacts

Public ContactDr Kishan PV

Sanzyme Biologics P Ltd

Kishan.pokuri@sanzyme.com04048589999

Outcome results