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A clinical study to assess the effects of a Bacillus coagulans-based product on protein digestion in gastro-intestinal tract

A prospective, randomized, double-blind, placebo-controlled parallel-group clinical trial to evaluate the effects of a Bacillus coagulans-based product on protein digestion and utilization in gastro-intestinal tract

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/048573
Enrollment
50
Registered
2022-12-28
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: Standard protein mix and Probiotic containing B. coagulans: 1 to 2 sachet to be taken orally with water once daily, at approximately the same time each day, preferably morning and night

Sponsors

Abode Biotec India Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subject has provided written and dated informed consent to participate in the study. 2.Subject is willing and able to comply with the protocol. 3.Healthy male/female of age 18-60 years. 4.Subject is in good health as determined by a health history questionnaire.

Exclusion criteria

Exclusion criteria: 1.Subject has a known allergy or sensitivity to any ingredient in the test product. 2.Subject on protein and/ or probiotic rich diet. 3.Subject has a history of alcohol or other drug abuse in the past year

Design outcomes

Primary

MeasureTime frame
1.Primary outcome measure(s) will be change from baseline in Creatine Kinase and CRP Score (measured after exercise bout) at day 1, week 4 and week8. Timepoint: 8 weeks

Secondary

MeasureTime frame
Improvement in the symptoms and signs of protein absorption and digestion, based on evaluation on Creatine Kinase and CRP and Pain VAS for muscle soreness, at the end of therapy.Timepoint: 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