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A Controlled parallel-group 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
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/07/026453
Enrollment
50
Registered
2020-07-09
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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 (8 wks): 106-108 CFU in the form of powder to be reconstituted in milk or water to be consumed in morning and evening (one each)(8 wks) Control Interv

Sponsors

Abode Biotec India Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

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 including the potential risks and side effects. 5. Subjects who are willing to complete all study procedures including study related questionnaires and comply with study requirements. 6. Subjects who have given voluntary, written, informed consent to participate in 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 6. Subjects suffering from Abnormal blood pressure 7. Subjects who are allergic to ingredients of the study product 8. Subjects who are using any other pre/pro/symbiotic product. 9. Subjects who are Smoker or alcoholic 10. Subjects who have participated prior in conflicting clinical trial or have participated in the trial over the last 3months.

Design outcomes

Primary

MeasureTime frame
1. Immune Status Questionnaire (ISQ Score) 2. Perceived Stress Scale - 10 (PSS -10) Differences in hematological parameters (complete blood cell count, lipid profile, kidney and liver function parameters) between the intervention group and the placebo group over the study period.Timepoint: Day1, Week 4 and week 8—

Secondary

MeasureTime frame
ââ?¬Â¢ Differences in haematological parameters between the intervention group and the placebo group over the study periodTimepoint: Day1, Week 4 and week 8—

Countries

India

Contacts

Public ContactDivya C

BioAgile Therapeutics Pvt Ltd

pm@bioagiletherapeutics.com08043754520

Outcome results

None listed

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