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A clinical study to assess the effect of a Bacillus coagulans-based product on immunomodulation and stress levels

A prospective, randomized, double-blind, placebo-controlled parallel-group clinical trial to evaluate the effect of a Bacillus coagulans-based product on immunomodulation and stress levels.

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/01/048720
Enrollment
50
Registered
2023-01-04
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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 containing B.coagulans: 106-108 CFU in the form of powder to be reconstituted in milk or water to be consumed in morning and evening (one each) for 8 weeks Control Interventi

Sponsors

Abode Biotec India Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Healthy male/female of age 18-65 years. 2.FBG ( 3.Normal blood parameters (Hb >= 10 g/dl). 4.Subjects who understand the nature and purpose of the study

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1.Differences in hematological parameters such as CBC in-between the 2 groups over the study period. 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

Countries

India

Contacts

Public ContactDivya C

Bioagile Therapeutics Pvt. Ltd

divya@bioagiletherapetics.com9538961761

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026